Total 15 product specialist job vacancies in Quality Assurance / Control category in George Town

The plant in Singapore (located in Jurong Island) is new and combines monomer and polymer productions. It is the result of exceptional investments and aims to support strong demand from the customers in Asia.

We are inviting passionate individuals to COME and JOIN us. Be part of our team, ARKEMA! We are seeking a self-driven team player with excellent communication skills and able to work independently with minimum supervision, equipped with excellent data collecion and analysis skills and attentive to details.

OBJECTIVES

• Comply with company quality assurance standards,
• Coordinates external and Internal Non conformance System,
• Document and track quality issues to identify trends and areas for improvement,
• Upkeep Lab Quality KPI including monthly reports,
• Creates a comprehensive monthly, quarterly and yearly overview of non-conformances; determining trends and insights.

MAIN JOB RESPONSIBILITIES

QUALITY (50%)

• Support implementation of quality assurance procedures and policies,
• Mange document system for QA&QC,
• Manage quality master data in SAP and release of products,
• Manage Laboratory Information Management system (LIMS),
• Provide training and support to employees on quality procedures and standards,
• Collaborate with cross-functional teams of the plant to identify quality improvement opportunities and ensure timely resolution of issues,
• Conduct internal audit to assess compliance with quality standards and regulatory requirements,
• Ensure readiness for Quality audit (internal and external),
• Continuously improve the effectiveness of the quality management system.

PRODUCT SUPPORT (30%)

• Provides the voice of the customer (VOC) as needed to ensure customer satisfaction and is the site quality contact for customer quality representative,
• Manage quality customer requests,
• Leads and/or participates in customer audits (including corrective & preventive action plan follow up),
• As a support to Sales and BD teams, leads complaints investigation based on complaint severity & customer requirements, up to and including containment processes and corrective and preventive actions (CAPA). The goal being to provide a timely, effective, response to the customer, utilizing various root cause analysis methodology (8D,5 Why etc.),
• Coordinate main MOC with customers: Packaging changes, RM changes, new assets homologation plan set up (internal / external) and execution follow up,
• Leads establishment & maintain of Customer Specifications ensuring plant capabilities are taken into consideration,
• Leads or provide support Io ensure product certification as needed,
• Assist Process team and Production team to master product quality, to homologate new raw material and new packaging,
• Maintain Raw Material Specifications,
• Hold responsibility & manage product orientation and/ or derogation.

HEALTH, SAFETY AND ENVIRONMENT (10%)

• Attend, participate and contribute to HSE programs and initiatives (zero target LTI, waste management, etc.
• Be an example and comply to HSE policies at any time.
• Carry out laboratory safety audits and ensure compliance. Conduct risk assessments Enforce waste management.

OTHERS (10%)

• Assist the Lab & QA Manager in his/ her absence.
• Other duties as assigned.

Education:

• Degree in Chemistry or equivalent, with minumum of 5 years of relevant experience.

Knowledge:

• Organic Chemistry, Polymers or equivalent, Quality Management, ISO 9001

Required Skills:

• Microsoft Office aplications
• SAP
• SPC
• LIMS will be an advantage

*SAP will be prioritizing candidates with full working rights in Singapore*

About SAP

A market leader in end-to-end business application software, SAP helps more than 425,000 customers worldwide work together more efficiently. We know that a diverse and inclusive workforce keeps us competitive and provides opportunities for all. We believe that together we can transform industries, grow economics, lift societies, and sustain our environment. Because it’s the best-run businesses that make the world run better and improve people’s lives. At SAP, we build breakthroughs, together.

About SAP Labs Singapore

SAP Labs Singapore is the 20th engineering hub in the SAP Labs Network and is the newest innovation hub at SAP that drives product leadership, fosters the best talent, and aims to boost ecosystem and community engagement with a variety of initiatives.

SAP Labs Singapore has the ambition to expand significantly and become the Embedded Artificial Hub for SAP, leveraging on core competencies in the current teams.

Your future team

Artificial Intelligence team as part of SAP Labs Singapore has experienced professionals taking on challenges posed by the SAP customers. Based in Singapore, you will have the opportunity to work on breakthrough projects addressing real-world problems, challenging norms with some of the SAP’s key customers. As part of the global product engineering team, you will participate in rich and engaging conversations with experts around the globe.

SAP Labs Singapore provides an open, modern working environment and the opportunity to become part of the global SAP engineering community.

Purpose and Objectives

As Quality Associate / Specialist, you will work together with a team of dedicated experts including AI developers, AI scientists, data engineers, dev-ops engineers, and architects with a single goal of building the best-in-class AI products. You will work against fixed timelines and your success will be measured by the ability to deliver solutions matching the performance of top-notch artificial intelligence systems.

EXPECTATIONS AND TASKS

Your tasks include:

• Able to define quality and test strategies for cloud and machine learning based products respecting defined process- and product standards
• Analyzes, defines, implements and executes quality and test related activities according to quality and test strategy
• Creates a detailed test design incl. test system landscape definition and product standards, prepares tests (customizing & master data), authors and executes manual and/or automated tests
• Analyzes test results (issues) and takes appropriate follow-up actions
• Is subject matter expert for teams in terms of quality assurance and test related processes, methods and tools
• Initiates process or tool improvements
• Develop proficient product domain knowledge incl. relevant business processes & scenarios and a proficient understanding of customer needs
• Develop relevant knowledge about product and process standards, important legal requirements as well as quality assurance and test related tools
• Develop proficient knowledge and technical competencies of relevant programming languages and related development tools and processes
• Develop good knowledge of software development life cycle and Quality Assurance methodologies
• Ability to analyze complex integration issues
• Ability to work in global teams with different time zones

Educational and experience requirements

Required

• Degree in Computer Science or related field
• 0 to 3 years of working experience as Quality Associate, preferrable in AI focused cloud application development
• A solid foundation in computer science, with strong competencies in algorithms, data structures, objects-oriented programming, design patterns, multi-threaded programming, and software design principles
• Hands-on knowledge in at least one of the server/ client-side programming languages such as Java, Scala, Go, Python, C#, C++
• Experience using any source control tools like GIT
• Experience setting up CI processes using tools like Jenkins, GitLab etc.
• Experience with any unit testing frameworks such as JUnit, nUnit, Xunit, Jasmine, etc.
• API Testing
• Excellent written and communication skills in English language
• Familiar with Agile/Scrum methodologies
• Strong desire to overcome obstacles and make your work benefit SAP's customers
• Excellent written and communication skills in English language

Optional

• Experience with build automation tools (Maven, Gradle, Shell scripting etc).
• Experience with UI testing tools and technologies such as Cucumber, Selenium, Robot Framework, etc.
• Experience in using Performance Testing tools like Jmeter
• Knowledge of XML, web services testing (REST or SOAP)
• Operational knowledge of Linux distributions such as Redhat, Ubuntu, SUSE

Job Segment: Quality Assurance, Tester, Machine Learning, Deep Learning, Artificial Intelligence

The plant in Singapore, located in Jurong Island, is new and combines monomer and polymer production. It is the result of exceptional investments and aims to support strong demand from the customers in Asia. We are seeking a detail-oriented and motivated individual to join our dynamic team in the high-performance polymers manufacturing industry.

The ideal candidate works on analysis development and implementation, as well as on development projects related to IT and Laboratory Infrastructure.

OBJECTIVES

• To develop new methods and improve existing methods for the lab in Singapore.
• Coordinate with others lab on new methods.
• To participate with process, production to fix issues at Singapore facility.
• To provide backup to QC lab on routine analytical activities.

TECHNICAL SCOPE

• Handles development of Projects (new methods, e.g. NIR, Lab-infrastructure, etc.)
• Develop, document and validate new analytical methods as needed (accuracy) and train lab members on new analytical methods.
• Supports and follows special analysis outside control plans.
• Contribute to improve the performance of routine analytical methods.
• Establish SOP for new methods and contribute to the revision of the operating procedures.
• Participate on process studies, investigations and development studies on coordination with process and production.
• Validate and cross reference test on a regular and on-going basis with other BU sites
• Work in close coordination with experts from other related sites and R&D-centres
• Support to routine QC analytical teams in case of manpower shortage or workload increase

HEALTH, SAFETY, ENVIRONMENT, QUALITY AND MANAGEMENT SYSTEMS

• Implements rules/ procedures/ good practices based on Arkema Integrated Management System.
• Detects and address potential risks in HSEQ field.
• Implements improvement programs in accordance with site directions and priorities in HSEQ field.
• Respects and enforces waste management.

Education

• Bachelor in Chemistry with significant experience in chemical industrial plant laboratory or Master degree in Chemistry.

Knowledge

• Knowledge of various routine analytical techniques (methods/equipment) used in the laboratory.
• Knowledge in organic chemistry and hazardous chemicals.
• Knowledge in IT-systems (LIMS, SAP).
• Knowledge in chemical engineering and process
• Knowledge in statistical analysis preferred

Skills

• Good organizational skills.
• Rigorous scientific reasoning.
• Measurement quality management, knowledge of statistical methods.

Soft skills

• Team-player with communication skills and benchmark-spirit
• Autonomy
• Management of priorities
• Scientific curiosity

We are inviting passionate individuals to COME and JOIN us. Be part of our team, ARKEMA!

The plant in Singapore is new and combines monomer and polymer productions. It is the result of exceptional investments and aims to support strong demand from the customers in Asia.

About the Role

The person works on analysis development and implementation, as well as on development projects related to IT and Laboratory Infrastructure.

Objectives

• To develop new methods for the lab in Singapore
• Administration of Lab-related IT-systems (LIMS, SAP)
• Coordinate with others lab on new methods
• To participate with process, production to fix issues at Singapore facility

TECHNICAL SCOPE

• Handles development of Projects (new methods, LIMS/SAP, NIR, Lab-infrastructure)
• Validates the accuracy of newly developed methods.
• Supports and follows special analysis outside control plans.
• Contribute to improve the performance of routine analytical methods.
• Establish SOP for new methods and contribute to the revision of the operating procedures.
• Participate on process studies, and development studies on coordination with process and production.
• Work in close coordination with experts from other related sites and R&D-centres

HEALTH, SAFETY, ENVIRONMENT, QUALITY AND MANAGEMENT SYSTEMS

• Implements rules / procedures / good practices based on Arkema Integrated Management System.
• Detects and address potential risks in HSEQ field.
• Implements improvement programs in accordance with site directions and priorities in HSEQ field.
• Respects and enforces waste management.

Education:

• Degree in chemistry, significant experience in industrial plant Laboratory

Knowledge:

• Knowledge of various routine analytical techniques (methods/equipment) used in the laboratory
• Knowledge in organic chemistry and hazardous chemicals
• Knowledge in IT-systems (LIMS, SAP)

Skills:

• Good organizational skills
• Rigorous scientific reasoning
• Measurement quality management, knowledge of statistical methods

Soft skills:

• Team-player with communication skills and benchmark-spirit
• Autonomy
• Management of priorities
• Scientific curiosity

Responsibilities:

• Conduct comprehensive IT compliance assessments to evaluate adherence to regulatory requirements, industry standards, and internal policies.
• Collaborate with business and IT stakeholders to identify compliance gaps and develop remediation plans to address issues effectively.
• Track and monitor key risk indicators related to IT operations, ensuring timely identification and mitigation of potential risks.
• Assist in the development and enhancement of IT risk management frameworks, policies, and procedures to strengthen the organization's risk posture.
• Support internal and external audits by providing documentation, evidence, and guidance on IT compliance and risk management practices.
• Facilitate regular communication and training sessions to raise awareness of IT compliance and risk management practices across the organization.
• Stay informed about emerging regulatory requirements, industry trends, and best practices in IT compliance and risk management to ensure ongoing effectiveness.

Requirements:

• Bachelor's degree or above in IT relevant majors.
• Minimum of 2 years of experience in IT compliance, risk management, or audit roles.
• Strong understanding of regulatory frameworks such as SOX, GDPR, HIPAA, or other relevant industry standards.
• Proficiency in conducting IT compliance assessments, risk assessments, and developing remediation plans.
• Excellent analytical skills with the ability to identify and prioritize risks effectively.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Relevant certifications such as Certified Information Systems Auditor (CISA), Certified Information Security Manager (CISM), or similar credentials are preferred.
• Ability to work independently and manage multiple tasks in a dynamic environment.

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role

Quality Assurance Specialist is to promote and integrate quality into every aspect of our BioReliance® biologics safety testing business in Singapore. The role is to perform batch record review (i.e. data audits) to support all aspects of quality operations to ensure that laboratory testing operates in full compliance with sound scientific practice, GxP and Standard Operating Procedures (SOPs). The scope of responsibility is to contribute or impact the results of the QA team and is accountable for the quality of own work, solve problems of low complexity independently by identifying and selection solutions and by analyzing information.

The post holder will be able to perform the following functions independently, with minimal guidance.

What You Do

• Batch record review: Review and approval of GxP documents, including Protocols, Technical Specification (TS), Batch Records, Workbooks, SOPs and all other QMS documentation.
• Batch record review: Comply with all applicable policies, procedures and guidelines.
• Batch record review: Conduct in-process or final audits and approval on manufacturing or testing documentation as they comply with the stated regulatory standards and the approved TS, protocol or SOPs.
• Batch record review: Release of the certificate of analysis for GMP testing against the TS and associated documentation.
• Batch record review: Prepare QA statement within each GLP final report specifying inspections date, and dates findings were reported to the Study Director and management.
• Review and approve deviations, anomalous results, OOS, positive results and CAPAs.
• Assist in investigations from events, complaints or data audits.
• Conduct trend analysis for deviations and review / approve applicable CAPA records.
• Assist self-inspections to ensure continuous improvement.
• Perform and support client audits, regulatory inspections.
• Perform and support internal audits.
• Perform and support supplier audits.
• Comply with Health and Safety Executive regulations and undergo relevant training modules when required and actively takes necessary action when encountering unsafe situations.
• Perform their duties according to the principles of Good Laboratory (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).

The above list of job duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post. Job descriptions will be regularly reviewed to ensure they are an accurate representation of the post

Who You Are

• Graduate degree in life sciences or higher related degree
• Minimum of 2 – 4 years of experience, within a similar Quality Assurance role i.e. batch record review.
• Shows a desire and motivation to work in Quality and regulated environment.
• Awareness of Biologics regulatory environment and GMP manufacturing topics.
• A proactive approach to all aspects of Quality.
• Fluent in both written and spoken English.
• Good communicator, dealing directly and effectively with operational teams and site QA and lab colleagues routinely.
• Strong analytical and problem solving abilities.
• Organized and logical in defining workload and delivering projects.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

• Advisory on SG regulations to SG Business Units (Deposits, Loans, Investments, Marketing, and Operations) for new product and system launches, as well as on BAU basis after each launch
• Manage compliance risks and uphold compliance with SG regulations for all functions throughout the bank
• Participate in system configuration discussions and UAT (including reviewing business SOPs)
• Highlight new regulations and regulatory expectations to various business and corporate functions and senior management, and help operationalize, where necessary
• Perform assessments on regulatory escalations and make recommendations for remediation measures
• Conduct Key Obligation Register exercise covering Business and Support Units
• Establish SG-wide assurance guidelines, drawing from higher risk areas based on internal risk reviews and assessments
• Perform assurance testing, identifying any compliance gaps in business processes and workflows, and make recommendations for remediation measures
• Monitor remediation plans for completed compliance tests
• Assist to prepare any relevant materials for training and management reporting purposes

Requirements:

• Bachelor’s degree or higher in Accountancy, Banking or Business equivalent
• 7-12 years of relevant experience in the space of regulatory compliance, including Anti-Money Laundering, consumer/corporate/investment products, operational risk management, technology risk management, and preferably with Banks, Financial Institutions, or reputable consulting firms
• Relevant regulatory compliance experience to support retail products such as unsecured facilities, credit card, personal wealth investment and insurance is a plus
• Good project management and problem-solving abilities with an eye for detail
• Excellent written and verbal communication skills
• Excellent interpretation of laws and regulations
• Able to work effectively with internal and external stakeholders
• Builder mindset, proactive, and a can-do attitude

Job Description:

Internal Processes and Reporting

1. Establish and maintain Quality Management System in both local and SEA region.
2. Develop or update procedures and SOPs for quality system process to ensure continuous process improvement is met.
3. Support audit readiness, conduct and prepare for regulatory or external audit as well as internal quality audits to ensure timely execution according to defined schedules.
4. Execute recall or field corrective actions and other post-market surveillance activities within impacted countries in the SEA region.
5. Participate in handling non-conformity, corrective and preventive actions, documentations, supplier quality across the organization’s sites.
6. Assist administration of management review process, including maintaining compliance to quality system data metric analysis, monitor and trend quality indicators to proactively report or escalate issues to QRA manager.
7. Track and monitor both Singapore and Regional KPIs including QA performance and develop monthly and/or quarterly analysis and reports for reporting to Management.
8. Execute other tasks and projects, as assigned by QRA manager.

Project Support, Training and Continuous Improvement

1. Provide QA support to new business development projects for potential or new onboarding customers.
2. Conduct training (both internal and refresher training) on standards and procedure, quality related programs and quality management procedure.
3. Conduct process mapping and identify areas of improvement and implement steps required to improve processes within QA and other functions.
4. Responsible for planning and implementation of QA related projects.

Minimum Qualifications:

• Degree holder in Life science, biomedical engineering-related field or equivalent experience.
• Strong attention to details.
• Excellent communication and interpersonal skills with ability to work collaboratively and influence cross-functional team.
• Able to converse in proficient Chinese.
• Problem-solving mindset and the ability to drive continuous improvement.
• Familiar with GDP and GDPMDS is a plus.
• Familiar with quality management methodologies (e.g., Six Sigma, Lean, Root Cause Analysis) is a plus.
• Having quality assurance experience is a plus.

• 30% resource for global ITC activity as APAC focal points contact
• Work with external advisors to classify the export control numbers (ECCN’s, Control list numbers etc) for all products in line with US, EU, China and other trade regulations
• Manage the integrity of trade data in Asia Pacific Region;
• Identify and analyze global trends and requirements regarding compliance functions, programs, and risk management, develop metrics and indicators
• Drive scalable business solutions with Veolia Engineering, Commercial, Manufacturing, Operations, Logistics, Tax and other business teams to ensure compliance with Global Trade Regulations
• Assist Business Development, Contracts and Operations in identifying export related requirements in new business transactions
• Work with manufactures/vendors/taggers to set up the effective import / export processes to support operations
• Support Export Control Classification Number (ECCN) classifications for international shipments on a regular basis
• Develop framework for enhanced classification program utilized globally for determination of proper classification of materials and accurate payment of duties and taxes applicable

Requirements:

• Strong technical skills and experience with ECCN and HTS classification determination
• In-depth knowledge on import/export regulations and activities
• Prior experience with developing and implementing International Trade Compliance programs in MNC
• Experience with encryption technology and application to export controls preferred
• B.S or equivalent degree - Highly preferred
• Experience working with a Global Trade System such as SAP GTS preferred
• At least 3-5 years of Global Trade related experience preferred
• Experience with global trusted trader programs such as AEO, CSA, NEEC or other similar programs a plus
• Must be able to work with multiple cross functional and cross geographical teams

We are looking for a Quality Assurance Specialist who can join immediately to support our quality management system development and implementation, ensuring product development in compliance with ISO 13485 and US Quality System Regulation (QSR). This role will be responsible for daily tasks involving maintaining and our quality processes including but not limited to documentation control, training program, tracking quality performance matrix, and gap analysis.

Responsibilities:

• Quality System Compliance: Ensure adherence to ISO 13485 standards, US QSR and internal SOPs throughout the product development and manufacturing processes.
• Document Control and Change Management: Manage and maintain the document control system to ensure accuracy and accessibility of quality documents. Assist in the development and implementation of quality management policies, procedures, and documentation through change control process.
• Risk Management: Participate in risk assessments and support risk management activities to identify and mitigate potential quality issues.
• Regulatory Compliance: Stay updated on relevant regulatory requirements and standards applicable to medical devices and ensure compliance.
• Quality Audits: Participate in internal and external audits, providing support for corrective and preventive actions (CAPA).
• Supplier Quality: Assist in monitoring supplier and part performance to ensure the quality of components and materials used in the manufacturing process.
• Quality Training: Assist in providing training and guidance to employees on quality assurance practices.
• Non-Conformance Management: Assist in investigating and addressing non-conformance issues, facilitating root cause analysis and corrective actions.
• Continuous Improvement: Contribute to ongoing process improvement initiatives to enhance product quality and efficiency.

Qualifications:

• Diploma or bachelor’s degree with 1-2 years of work experience in a quality assurance role, preferably in the medical device industry.
• Fair theoretical and practical knowledge in ISO 13485 and US QSR.
• Excellent problem-solving and analytical skills.
• Effective communication and interpersonal skills.
• Detail-oriented and able to work independently and in a team.

Key Responsibilities:

• Design, maintain, and scale automated test frameworks and unit tests for Unity3D applications, ensuring comprehensive coverage and reliability.
• Integrate automated and unit testing within the GitHub CI/CD pipeline to ensure tests are executed as part of the development lifecycle.
• Utilize Unity-specific testing tools, including the Unity Test Framework, to develop and execute automated and unit tests.
• Manage bug tracking and test case management using Jira, with Zephyr to streamline test planning and execution within the Unity development workflow.
• Develop detailed automated and unit test plans and test cases, and maintain them for Unity3D projects.
• Optimize automated and unit testing strategies and tools to meet the unique needs of Unity3D development.
• Analyze test results, document systematically, and collaborate with the development team for issue resolution.
• Stay informed on the latest Unity3D releases, automated testing technologies, and best practices to continuously improve the testing process.

Qualifications:

• A Bachelor’s degree in Computer Science, Software Engineering, or a related field.
• 2 years of proven experience in QA automation and unit testing, with a focus on game development or interactive software testing within the Unity3D platform.
• Solid experience with Unity Test Framework for creating automated and unit tests.
• Expertise in GitHub for implementing CI/CD practices, especially within Unity3D development environments.
• Skilled in using Jira for issue tracking, with proficiency in Zephyr for managing test cycles.
• Strong communication abilities and a detail-oriented mindset as a collaborative team member.

We are looking for a Quality Assurance Specialist to support our quality management system and ensure product development in compliance with ISO 13485 and US QSR. The ideal candidate should have a background in engineering and 1-2 years of experience in a similar role. This role will be critical in maintaining and improving our quality processes, ensuring the safety and efficacy of our medical instruments.

Responsibilities:

• Quality System Compliance: Ensure adherence to ISO 13485 standards, US QSR and internal SOPs throughout the product development and manufacturing processes.
• Document Control and Change Management: Manage and maintain the document control system to ensure accuracy and accessibility of quality documents. Assist in the development and implementation of quality management policies, procedures, and documentation through change control process.
• Risk Management: Participate in risk assessments and support risk management activities to identify and mitigate potential quality issues.
• Regulatory Compliance: Stay updated on relevant regulatory requirements and standards applicable to medical devices and ensure compliance.
• Quality Audits: Participate in internal and external audits, providing support for corrective and preventive actions (CAPA).
• Test Method Development and Evaluation: Collaborate with cross-functional teams to develop and validate test methods for product quality evaluation.
• Supplier Quality: Assist in monitoring supplier and part performance to ensure the quality of components and materials used in the manufacturing process.
• Quality Training: Assist in providing training and guidance to employees on quality assurance practices.
• Non-Conformance Management: Assist in investigating and addressing non-conformance issues, facilitating root cause analysis and corrective actions.
• Continuous Improvement: Contribute to ongoing process improvement initiatives to enhance product quality and efficiency.

Qualifications:

• Bachelor's degree in Engineering or a related field.
• 1-2 years of experience in a quality assurance role, preferably in the medical device industry.
• Strong knowledge of ISO 13485 and US QSR.
• Excellent problem-solving and analytical skills.
• Effective communication and interpersonal skills.
• Detail-oriented and able to work independently and in a team.

QA/RA Specialist – Job Description:

Iota Medtech together with healthcare innovators & radiologists are co-creating AI solutions to be deployed into hospital & healthcare settings. We envision a future where our AI platform & Software-as-a-Medical-Device transforms healthcare for a billion people by assisting clinicians and improving patient outcomes.

Roles & Responsibilities:

1. Develop regulatory pathway to obtain regulatory approval and access to key markets for the product/s.

2. Develop the quality management system (QMS) that meets the regulatory requirements of ISO 13485 compliance.

3. Achieve and maintain ISO 13485 certification.

4. Execution of the established QMS and compliance to regulations.

Quality Assurance (QA):

1. Implement and maintain quality management system policies and procedures and ensure compliance with relevant international standards and regulatory requirements.

2. Review, revise and route documents for qualification and approval.

3. Manage internal and external audits.

4. Participate in post-market surveillance.

Regulatory Affairs (RA):

1. Work with product development, clinicians and other applicable departments and external organisations to support registration requirements.

2. Review documentation and supporting evidence to ensure applicable regulatory requirements are met.

3. Manage product registration, dossier preparation, including change notification and renewal, for submission to regulatory authority (example HSA) and monitor the progress and timeline.

4. Maintain product registration record to ensure proper documentation and record filing.

5. Responsible to ensure that regulatory clearances are obtained in a timely manner in line with expected project/business plans and responds to potential submission deficiencies.

Job Requirements

1. Diploma/degree in biomedical engineering or equivalent/relevant discipline.

2. Clear understanding of Quality and Regulatory standards & ISO 13485.

3. Team player, detailed oriented, with excellent verbal & written communication.

*SAP will be prioritizing candidates with full working rights in Singapore*

About SAP

A market leader in end-to-end business application software, SAP helps more than 425,000 customers worldwide work together more efficiently. We know that a diverse and inclusive workforce keeps us competitive and provides opportunities for all. We believe that together we can transform industries, grow economics, lift societies, and sustain our environment. Because it’s the best-run businesses that make the world run better and improve people’s lives. At SAP, we build breakthroughs, together.

About SAP Labs Singapore

SAP Labs Singapore is the 20th engineering hub in the SAP Labs Network and is the newest innovation hub at SAP that drives product leadership, fosters the best talent, and aims to boost ecosystem and community engagement with a variety of initiatives.

SAP Labs Singapore has the ambition to expand significantly and become the Embedded Artificial Hub for SAP, leveraging on core competencies in the current teams.

Your future team

Artificial Intelligence team as part of SAP Labs Singapore has experienced professionals taking on challenges posed by the SAP customers. Based in Singapore, you will have the opportunity to work on breakthrough projects addressing real-world problems, challenging norms with some of the SAP’s key customers. As part of the global product engineering team, you will participate in rich and engaging conversations with experts around the globe.

SAP Labs Singapore provides an open, modern working environment and the opportunity to become part of the global SAP engineering community.

Purpose and Objectives

As Quality Associate / Specialist, you will work together with a team of dedicated experts including AI developers, AI scientists, data engineers, dev-ops engineers, and architects with a single goal of building the best-in-class AI products. You will work against fixed timelines and your success will be measured by the ability to deliver solutions matching the performance of top-notch artificial intelligence systems.

EXPECTATIONS AND TASKS

Your tasks include:

• Able to define quality and test strategies for cloud and machine learning based products respecting defined process- and product standards
• Analyzes, defines, implements and executes quality and test related activities according to quality and test strategy
• Creates a detailed test design incl. test system landscape definition and product standards, prepares tests (customizing & master data), authors and executes manual and/or automated tests
• Analyzes test results (issues) and takes appropriate follow-up actions
• Is subject matter expert for teams in terms of quality assurance and test related processes, methods and tools
• Initiates process or tool improvements
• Develop proficient product domain knowledge incl. relevant business processes & scenarios and a proficient understanding of customer needs
• Develop relevant knowledge about product and process standards, important legal requirements as well as quality assurance and test related tools
• Develop proficient knowledge and technical competencies of relevant programming languages and related development tools and processes
• Develop good knowledge of software development life cycle and Quality Assurance methodologies
• Ability to analyze complex integration issues
• Ability to work in global teams with different time zones

Educational and experience requirements

Required

• Degree in Computer Science or related field
• 0 to 3 years of working experience as Quality Associate, preferrable in AI focused cloud application development
• A solid foundation in computer science, with strong competencies in algorithms, data structures, objects-oriented programming, design patterns, multi-threaded programming, and software design principles
• Hands-on knowledge in at least one of the server/ client-side programming languages such as Java, Scala, Go, Python, C#, C++
• Experience using any source control tools like GIT
• Experience setting up CI processes using tools like Jenkins, GitLab etc.
• Experience with any unit testing frameworks such as JUnit, nUnit, Xunit, Jasmine, etc.
• API Testing
• Excellent written and communication skills in English language
• Familiar with Agile/Scrum methodologies
• Strong desire to overcome obstacles and make your work benefit SAP's customers
• Excellent written and communication skills in English language

Optional

• Experience with build automation tools (Maven, Gradle, Shell scripting etc).
• Experience with UI testing tools and technologies such as Cucumber, Selenium, Robot Framework, etc.
• Experience in using Performance Testing tools like Jmeter
• Knowledge of XML, web services testing (REST or SOAP)
• Operational knowledge of Linux distributions such as Redhat, Ubuntu, SUSE

Job Segment: Quality Assurance, Tester, Machine Learning, Deep Learning, Artificial Intelligence

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role

The individual performs a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation.

Scope of Responsibility: Impacts a range of important customer, operational, project or service activities within the Quality Assurance (QA) team as well as Operations teams. Solves problems of varying complexity independently by identifying and selecting solutions and by analysing information.

What You Do

• Act as the Main Point of Contact for all compliance related activities
• Lead and/or support client regulatory submissions, client audits and supplier audits. Follow up on committed actions.
• Lead and/or support regulatory inspections.
• Coordinate between departments for responses for audit findings and gap analysis
• Conduct laboratory inspections to include commissioning and/or internal audits as qualified lead auditor / co-auditor
• Review and approve client and supplier quality agreements.
• Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records.
• Review and approve change control (GCC) records.
• Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, and certificates of analysis.
• Review and approve validation files for systems and assays.
• Review and approve deviations / OOS records of varying impact and criticality.
• Conduct trend analysis for deviations and review / approve applicable CAPA records.
• Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics.
• Assist with tracking and trending of BRIQS records (events, CAPA, EC, etc.) for strategic clients, present metrics at meetings and provide support for quality improvements to address trends.
• Escalate significant quality issues impacting strategic clients and highlight at monthly / quarterly quality review board meetings.

The above list of job duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post. Job descriptions will be regularly reviewed to ensure they are an accurate representation of the post.

Who You Are

• Graduate degree in life sciences or higher related degree
• 4+ years of experience in Quality Assurance or related field within a GxP environment.
• Shows a desire and motivation to work in Quality and regulated environment.
• Awareness of Biologics regulatory environment and GMP manufacturing topics.
• A proactive approach to all aspects of Quality.
• Open-minded, flexible and works with agility.
• Works with cross-functional teams and builds networks within QA and Operations departments.
• Collaborates with various teams to identify and implement improvements.
• Willing to embrace and implement change on a global scale.
• Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
• Excellent communication, facilitation, and conflict resolution skills.
• Additional Local Needs: Global mindset and to be willing to engage in conference calls at out-of-office hours.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!