Total 664 Quality Assurance / Control job vacancies

Key Responsibilities

• Define and implement comprehensive test strategies, test plans, and testing processes & frameworks aligned with corporate guidelines and project objectives
• Establish and continuously improve testing processes, standards, and best practices
• Lead end-to-end test management across SIT, UAT, and other test levels/phases
• Drive test automation initiatives, including rollout and adoption of automation tools and frameworks
• Manage and mentor test teams, both onshore and offshore, providing leadership, supervision, and performance guidance
• Collaborate closely with business stakeholders, project managers, and technical teams to ensure alignment and delivery quality
• Ensure effective defect management, risk identification, and mitigation strategies
• Provide status reporting, metrics, and quality insights to senior management and stakeholders
• Oversee the implementation and optimization of test management tools and platforms

Requirements

• Diploma or Bachelor computer science or IT-related degree
• Minimum 8 years of experience in software testing
• Proven experience in test strategy, planning, and framework design
• Strong stakeholder management and communication skills across business and technical teams
• Demonstrated team leadership and supervisory experience
• Hands-on experience in test automation and/or test management tools implementation
• Strong understanding of SDLC, STLC, Waterfall and Agile methodologies
• Experience in transportation, payment systems domain is highly preferred
• Software testing certification such as ISTQB Certified Tester Foundation Level
• Comfortable to travel cross boarders when required
• Comfortable to manage and lead multiple project teams.

Quality Manager

We are seeking a Quality Manager to lead the company's Quality Management System (QMS) and ensure products, processes, and operations consistently meet customer, regulatory, and internal quality requirements. The role will oversee quality assurance and quality control activities, drive continuous improvement initiatives, and support customer and certification audits.

Key Responsibilities

• Manage and maintain the company's Quality Management System in accordance with ISO 9001 and ISO 13485 requirements.

• Lead the QA team and oversee incoming, in-process, and outgoing quality activities.

• Ensure products meet customer specifications, drawings, and quality standards.

• Investigate quality issues and drive effective corrective and preventive actions.

• Handle customer complaints, quality concerns, and audit requirements.

• Plan and conduct internal audits, management reviews, and continuous improvement initiatives.

• Work closely with Production, Engineering, and Project teams to improve process capability and product quality.

• Monitor quality performance metrics and implement actions to reduce defects and customer complaints.

• Manage calibration systems and ensure compliance of measuring equipment.

• Support supplier quality management and new product introduction activities.

Key Skills & Requirements

• Strong knowledge of ISO 9001 and ISO 13485 Quality Management Systems.

• Experience in quality management within a manufacturing environment, preferably plastic injection molding.

• Familiarity with quality tools such as 8D, FMEA, Root cause analysis etc.

• Strong leadership, communication, and problem-solving skills.

• Experience managing customer audits, certification audits, and quality documentation.

Job Description:

• In Charge of auditing and assessing the suitability of suppliers
• Responsible for initiating and managing project transfer
• Responsible for guiding and implementing improvement programs as well as negotiating and balancing capacity among suppliers
• Responsible for FA Inspection of casting and machining services
• In Charge of managing the foundries which include quality and delivery performance
• In charge of handling the non-conformance parts follow up
• Responsible for checking and monitoring suppliers to ensure delivery

Requirements:

• Min Diploma in Precision Engineering or relevant
• Min 5 years of experience in Metal Machining industry with experience in QC/ Audit
• Extensive travelling is required

To submit your application, please apply online apply@rn-care.com or call +(65) 6513 5697 for private and confidential discussion.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

RN Care Pte. Ltd
EA License No: 17C8900

Quality Assurance (QA)

• Working days: 5.5 days Alternate Saturday
• Working Hours: 8:30am-5:30pm
• Salary: $2300 - $3000 (depend on exp) 
• Working Location : Bedok

Job Responsibilities:

• Conduct detailed inspection on finished products to identify defects and non-conformities
• Handle quality issues and defective products found during production
• Liaise with customers on quality-related matters and complaints
• Work closely with production and QC teams to investigate root causes of defects
• Coordinate with internal teams on corrective and preventive actions
• Prepare FA reports and quality documentation
• Propose process improvement to enhance product quality
• Review inspection data and maintain proper quality records
• Ensure products meet customer specifications and quality standards

Job Requirements:

• Experience in QA / QC within plastic injection moulding or manufacturing industry
• Able to interpret 2D drawings
• Familiar with quality inspection processes and FA reports

Ho Ming Jie (Edmund) Reg No: R1987094

The Supreme HR Advisory Pte Ltd EA No: 14C7279

Job Description & Requirements:

Test Program Manager will work closely with the respective stakeholders across the organisation to drive testing Projects which is aligned to organisation's transformation strategy.

Reporting to the Digital Domain Lead, the candidate will ensure the overall successful delivery of all testing services for Cross Border Payments + NPS Enhancements and upgrade Project, change requests and production fixes under Digital domain suite of applications.

The candidate is also expected to manage and ensure the successful delivery of testing services provided by organisation's appointed test service providers, and in accordance with the organization’s standards and processes.

·        Overall accountable and responsible for delivery of testing services one or more applications and/or projects of Digital domain applications.

·        Manage and oversee the day-to-day delivery of test services by Bank appointed vendors in the conduct of testing.

·        Works with the testing service providers and other client stakeholders to review, provide feedback and sign off on the test strategy, test plans and other test service providers’ artefacts for the testing service delivery.

·        Coordinates with the Test Governance team to ensure adoption of testing methods, standards and tools, and to coordinate any health checks or audits.

·        Ensures that any changes to the scope of services are communicated to the respective test service providers and the impact is factored in to the plan.

·        Engages with various client stakeholders(including but not limited to, application, security, infrastructure, business), testing service providers to ensure testing services meet the banks’ objectives and demand.

·        Act as the first point of escalation for any issues raised by client stakeholders, testing service providers.

·        Quantify, manage, track and report test related statuses, SLA and KPIs, and ensure that defined testing transformation SLA and KPI targets are met for the portfolio accountable.

·        Drive and collaborate with all client stakeholders and test service providers to plan all testing related deliveries for the portfolio accountable.

·        Participate and contribute in forums, as required, to drive testing transformation and innovation.

·        Works closely with the Test Engineering Lead to provide inputs around domain specific test engineering requirements and ensure that they are met.

·        Establishes and maintains effective working relationships with the Vendor Test Managers/Test Leads for the respective domains.

Engages stakeholder communities to get their feedback on testing service delivery and identify improvement opportunities to be fed back to the Test CoE team.

Requirements:
·        Bachelor’s Degree or Master’s degree in computer engineering or related field.

·        Proven working experience in test delivery or equivalent role with at least 10 to 15 years relevant experience in large and complex organization's preferably in the area of Banking and Finance and at least 5 years’ senior manager experience in testing.

·        Extensive experience in managing end to end delivery of testing services from multiple vendor test service providers.

·        Proven experience in testing standards, tools, processes & methodologies, frameworks, and various delivery methodologies e.g. Agile, Hybrid Agile and Waterfall, DevOps.

·        A proven, successful track record of managing shared IT service development and/ or IT Testing Services.

·        Demonstrated success in developing highly effective working relationships with internal and external stakeholders to deliver collaboration, partnerships and services.

·        Strong attention to details, excellent analytical and problem-solving skills.

·        Experience in managing multiple external testing service providers.

·        Experience in managing multi-cultural, diverse, direct and virtual teams.

·        Must display a high level of professional judgment, commitment, integrity, and teamwork.

·        Excellent client facing, internal communications, written and verbal communication skills.

·       Testing or quality certifications, PMP certifications, ISTBQ and Test Maturity Model integration (TMMi) Framework awareness will be preferred.

• Should have a minimum of 5 years of experience in managing projects in Banking and Finance domain.
• Strong domain knowledge in Digital Domain. Experience in managing testing one or more areas of these domains will be an advantage.
• Experience in various testing tool suites like Tosca, Selenium, Appium, JIRA, Query Surge, LoadRunner/Performance Centre.

Interested candidates, who wish to apply for the above position, please send in your resume ajay.sharma@persolapac.com 

We regret to inform that only shortlisted candidates will be contacted

PERSOL Singapore Pte Ltd EA License No. 01C4394 EA Reg No: R24123179 (Ajay Sharma)

By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOL Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for the purposes setout in the Privacy Policy available at https://www.persolsingapore.com/policies.You acknowledge that you have read, understood, and agree with the Privacy Policy.

Job Description:

• Work as a team to create and implement comprehensive quality assurance plans that outline the processes and procedures for ensuring quality throughout the product lifecycle, from design to manufacturing to delivery.
• Conduct internal and external audits to assess the effectiveness of quality control procedures and identify areas for improvement.
• When quality issues are identified, work to determine the root cause of the problem, develop corrective actions, and monitor their implementation to ensure they are effective.
• Ensure that company's products and services meet relevant industry standards and regulations, including standards like NADCAP.
• Provide training and awareness programs for employees on quality control procedures and best practices.
• Actively participate in continuous improvement projects to enhance quality and reduce costs.
• Collaborate with suppliers to ensure that their products and services meet the required quality standards.

Requirement:

• Min degree in Engineering
• Min 3 years of experience in certifying staff and lead QA activities

To submit your application, please apply online to apply@rn-care.com or call +(65) 6513 5697 for private and confidential discussion.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

RN Care Pte. Ltd
EA License No: 17C8900

About Us

Green Link Digital Bank is Singapore's inaugural wholesale digital bank focusing on supply chain finance, mainly serving MSMEs and aiming to help MSMEs grow and improve digitization.

We are looking for a passionate and inquisitive individual to join us in our pioneering mission to build a best-in-class digital bank for our target customer segments. Join our Legal & Compliance team as a Compliance Analyst and be a part of a high performing team that at the front lines of defense, building and making tangible impact to our business, and not merely checking boxes. If you thrive in a fast-paced results-oriented environment, you are who we want so let us start this conversation now!

Responsibilities

• Provide regulatory compliance advisory to business units on applicable laws, regulations, MAS notices, guidelines, and internal policies.
• Manage the upkeep of Bank’s regulatory compliance matrix by managing regulatory changes and advising business units on regulatory implication.
• Review and provide 2nd line challenge on regulatory breach assessments
• Review and update compliance policies, procedures, and controls to ensure alignment with regulatory expectations.
• Provide compliance training and regulatory awareness programs to employees.
• Support compliance risk assessments and contribute to the development of risk mitigation measures.
• Assist in regulatory projects, policy enhancements, and remediation initiatives arising from audits or regulatory reviews.
• Prepare management reporting and present compliance-related updates to senior stakeholders.
• Support requests from regulators, audits, and internal governance committees.
• Provide cross-coverage support to AML team on KYC and transaction monitoring matters.

Requirements

• A recognised University degree in Law, Business, Finance or related discipline.
• 3-6 years’ relevant experience in regulatory compliance with banks, financial institutions, audit firms and/or compliance consultancy firms.
• Familiar with MAS regulations in relation to banking regulations and ML/TF.
• Strong grasp of corporate transactions, MAS regulations, and banking products.
• Familiarity with payments and cryptocurrency AML and sanctions programs are desirable.
• Interest in the digital payment tokens and/or DPT service provider’s space.
• Good interpersonal and communication skills.
• Resilient and takes well to criticism.
• Adaptive, proactive, independent, and resourceful.
• Embodies teamwork.

By submitting your application, you have given your consent for us to collect, use and retain your data fora year as according to our prevailing data retention and PDPA policies. Should you have any enquiries onour data policy, please contact us at CustomerSupport@glbank.com.

1. Formulates, establishes and implements company QA systems, programs and activities.

2. Develops methods for inspection, testing, sampling and training to ensure ongoing quality improvement processes.

3. Investigates complaints and provide timely responses in accordance with defined procedures.

4. Works closely with suppliers, customers and internal staff to meet the quality requirements.

5. Assists Executive9s) in handling audits from internal and external sources (ISO, customers, suppliers).

Responsibilities:

• Maintain accurate and up-to-date ISO 9001, ISO 14001, and ISO 13485 documentation, including Quality Manuals, procedures, work instructions, and records, to ensure system compliance and management review readiness.
• Plan, coordinate, and conduct internal and external audits to ensure organizational readiness for third-party certification, management reviews, and customer audits.
• Collaborate with internal stakeholders to support and participate in customer and supplier audits to ensure compliance requirements are met.
• Review audit findings, develop corrective action plans, and drive continuous improvement initiatives.
• Generate and review supplier quality performance reports, work closely with suppliers to resolve non-conformances, and promote continuous improvement.
• Issue, monitor, and follow up on Supplier Corrective Action Requests (SCAR), ensuring effectiveness and timely closure.
• Support qualification and onboarding of new suppliers to maintain a robust pipeline aligned with production requirements.
• Manage calibration schedules and preventive maintenance programs for equipment to ensure operational reliability and compliance.
• Address quality issues arising from production and customer feedback by working closely with production teams to implement corrective actions and resolve customer complaints with proper documentation.
• Ensure timely closure of Corrective and Preventive Actions (CAPA), non-conformance reports, and customer complaints, and publish quality performance reports.
• Lead Material Review Board (MRB) meetings with cross-functional teams to perform root cause analysis, implement corrective actions, and verify effectiveness.
• Supervise and lead QC inspectors to ensure parts inspection compliance with engineering drawings and quality standards.

Qualifications:

• Diploma in Quality Management, Engineering, Manufacturing, or a related field.
• Min 3 years of relevant experience in quality or manufacturing environments, with exposure to audits and documentation.
• Basic understanding of supplier management and quality coordination.
• Familiarity with commonly used quality management standards (e.g. ISO systems).
• Working knowledge of quality tools and process control methods.

We regret only shortlisted candidates will be contacted. All applications will be handled confidentially. By submitting your application, you agree to the collection, use, retention, and disclosure of your personal information to prospective employers.

Wecruit Pte Ltd

EA License No: 20C0270

EA Personnel: Nyon Hock Sen (Aden)

EA Personnel Reg No: R24124070

AssistantManager, Quality Assurance & Quality Control

Job Description & Requirements

Responsibilities:

- Ensure the implementation and maintenance of allquality and food safety control processes are being complied to company’sstandard, HACCP, ISO and local statutory requirement.

- To conduct in house food safety training toproduction/operation staffs.

- To manage customer complaints investigation andperform troubleshooting and drive processimprovement program to ensure high standard of food safety and quality.

- Provide technical advice to support anotherdepartment as and when necessary

- Monitoring product integrity and conduct producttesting for new and regular products.

- To support Production Manager for admin work.

- Manage external inspection and liaise withregulatory agencies

- To kick start sustainability initiatives for the company putting in process andcertification.

- Train junior QA to perform her role as QA executive.

- Perform ad-hoc duties as assigned by management

Summary

Our client, a top-tier data center customer, is seeking a Quality Inspector to join their growing team. This organization specializes in delivering new product introductions for data centers, managing the full end-to-end lifecycle—from initial consultation and design through to engineering, supply chain management, mass production, logistics, and ongoing support.

Responsibilities

• Conduct product inspections and quality checks.
• Assist with failure analysis and reporting
• Maintain good housekeeping and 5S standards within the work area
• Able to support Shift Work 

Minimum Qualifications

• At least 1-2 year of related working experience in manufacturing, testing, or production environments.
• Physically fit and healthy.
• Basic computer skills required - Hardware
• Able to use torque screwdrivers and multimeters.
• Proficient in Microsoft Office applications, including Word and Excel.
• Technical school, vocational school, or high school diploma and above.

We regret to inform that only shortlisted candidates will be notified.

EA Reg No: R25130007, JANANI ARRII D/O ARIVALAGAN

Allegis Group Singapore Pte Ltd, Company Reg No. 200909448N, EA License No. 10C4544

Responsibility
1. Perform visual inspection according to specifications/Instructed.
2. Ensure good housekeeping on work station at all times.
3. Inform QC supervisor/leader when product does not conform to specification.
4. Follow-up on specified instruction as and when advised by supervisor.
5. Maintain record for daily inspected lots/goods.

Report directly to QC Supervisor/leader

Requirement
1. Primary 6 and/or
2. Minimum 1-2 years industrial work experience. Willing to learn attitude.

• Assist to implement, maintain and to continuously improve on the ISO certification and system in relate to ISO 9001, ISO 22301 and ISO 27001
• Assist to review ISO 9001, ISO 22301 and ISO 27001 related manual, policies, procedures, business contingency plan and specified requirements and ensure they are implemented and complied to
• Assist to manage, participate and ensure all quality control and assurance processes / activities are in compliance to Company's standard, SOPs and WIs and customer’s requirements
• Facilitate and support in the review of processes and workflow to improve operational effectiveness
• Coordinate external audits and monitor corrective and preventive measures
• Participate in project, work studies, work committees, company-wide promotional activities and continuous improvement initiatives
• Conduct regular audits and compliance checks to assess quality performance, identify areas of improvement and monitor the corrective and preventive measures
• Ensure that corrective actions taken are adequate and analyse quality records for adverse trends
• Liaise with internal and external parties on QMS related issue
• Gather and prepare data from audits, compliance checks or any other areas as requested for management reporting
• Support company’s business effort and projects for client engagement and support, participate in the tender bidding
• Ensure that all information security management system related policies, procedures and specified requirements are implemented and complied to.
• Any other tasks as assigned by the supervisor

Requirement:

• Diploma or Degree in Science/Engineering from a recognized institution
• Preferably 2-3 years of work experience in Quality related work in the facilities management and/or engineering industry
• Preferably ISO 9001 Internal Auditor certified
• Preferably knowledge of Business Contingency Management System and Information Security System
• Proficient in MS Office applications
• Good written and verbal communication skills
• Resourceful and process good problem-solving skills
• Self-motivated and able to work well in a team
• Has a good safety mindset and displays good WSH behavior

• Monitor and ensure manufacturing processes comply with quality standards and customer specifications.
• Perform process inspections, product verification, and quality control activities.
• Analyze quality issues, conduct root cause investigations, and implement corrective actions.
• Collaborate with engineering, production, and suppliers to improve product quality and operational efficiency.

Requirements:

• Diploma and above
• At least 2 years of experience in manufacturing, OEM, precision engineering,
• Knowledge of ISO 9001, quality assurance systems, and manufacturing quality processes.
   

If you are keen to apply for the position, kindly email your detailed resume in MS Word to hr@recruit-expert.com

Please note that only shortlisted candidates will be notified.

For more job opportunities, please visit our website at www.recruit-expert.com

EA Licence: 19C9701

Registration: R1326740

Responsibilities:

• Maintain accurate and up-to-date ISO 9001, ISO 14001, and ISO 13485 documentation, including Quality Manuals, procedures, work instructions, and records, to ensure system compliance and management review readiness.
• Plan, coordinate, and conduct internal and external audits to ensure organizational readiness for third-party certification, management reviews, and customer audits.
• Collaborate with internal stakeholders to support and participate in customer and supplier audits to ensure compliance requirements are met.
• Review audit findings, develop corrective action plans, and drive continuous improvement initiatives.
• Generate and review supplier quality performance reports, work closely with suppliers to resolve non-conformances, and promote continuous improvement.
• Issue, monitor, and follow up on Supplier Corrective Action Requests (SCAR), ensuring effectiveness and timely closure.
• Support qualification and onboarding of new suppliers to maintain a robust pipeline aligned with production requirements.
• Manage calibration schedules and preventive maintenance programs for equipment to ensure operational reliability and compliance.
• Address quality issues arising from production and customer feedback by working closely with production teams to implement corrective actions and resolve customer complaints with proper documentation.
• Ensure timely closure of Corrective and Preventive Actions (CAPA), non-conformance reports, and customer complaints, and publish quality performance reports.
• Lead Material Review Board (MRB) meetings with cross-functional teams to perform root cause analysis, implement corrective actions, and verify effectiveness.
• Supervise and lead QC inspectors to ensure parts inspection compliance with engineering drawings and quality standards.

Qualifications:

• Diploma in Quality Management, Engineering, Manufacturing, or a related field.
• Min 3 years of relevant experience in quality or manufacturing environments, with exposure to audits and documentation.
• Basic understanding of supplier management and quality coordination.
• Familiarity with commonly used quality management standards (e.g. ISO systems).
• Working knowledge of quality tools and process control methods.

We regret only shortlisted candidates will be contacted. All applications will be handled confidentially. By submitting your application, you agree to the collection, use, retention, and disclosure of your personal information to prospective employers.

Wecruit Pte Ltd

EA License No: 20C0270

EA Personnel: Nyon Hock Sen (Aden)

EA Personnel Reg No: R24124070

• MNC Company

• Basic $3500 - $4000 + AWS + Variable Bonus

• Excellent Welfare and Benefits + Career progression

• Working location: Aljunied

• Working hours: Monday to Friday (9am to 6pm)
  

Job Responsibilities:

• Develops, implements, supports and/or leads process improvement efforts, quality initiatives, cross-functional efforts and sustainable corrective measures.

• Plans, facilitates or executes internal, customer, supplier or certification audits. Ensures corrective actions specific to non-conformance and audit results are appropriately robust and sustainable to maintain certifications.

• Collects and analyzes data obtained from internal quality audits, customer and supplier feedback, and process evaluations to identify opportunities to improve processes and procedures and ensure quality goals are achieved.

• Works closely and maintains good working relationship with internal department representatives, customers, suppliers, and/or external certification/regulatory representatives.

• Trains employees in continuous improvement techniques and the quality management system.

• Other duties as assigned.

Job Requirements:

• Possess minimum Bachelor’s Degree qualification or equivalent.

• Training will be provided for those lesser/without experience.
  

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities

• Current and Expected salary

• Reason for leaving

• Date of availability

• Education background
  

  
  

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

Job Description

Quality Management Systems / Quality Assurance Manager

Department:  Quality,Regulatory & Compliance
Location: Singapore
Reports to: Business Director
Employment Type:  Full-time, Permanent
Job Level: Manager / Senior Manager

About AITbiotech

AITbiotech Pte Ltd is aSingapore-based molecular diagnostics and bioinformatics company dedicated to advancing clinical decision-making through innovative genomic and diagnostic technologies. Our product portfolio — including abONE, abSEQ, abNEX, abGenix X,and abTES — serves clinicians and healthcare institutions across SoutheastAsia. We are committed to the highest standards of quality, safety, and regulatory compliance as we scale our operations and expand into new markets.

Role Overview

The QMS/QA Manager will be responsible for maintaining and continuously improving AITbiotech's Quality Management System in alignment with ISO 13485, HSA (Singapore MDA) regulations, and CE-IVD/IVDR requirements. This is a dual-focus role: ensuring our QMS operates robustly across all product lines while actively leveraging AI-assisted tools to modernise quality processes, documentation workflows, and regulatory intelligence. The successful candidate will be a pragmatic quality professional who understands both the regulatory landscape for in vitro diagnostics and the emerging potential of AI to enhance quality operations.

Key Responsibilities

1.  QMS Maintenance & Continuous Improvement

• Own and manage the end-to-end ISO 13485-certified QMS, including document control, change control, CAPA, internal audits, and management review processes.
• Conduct periodic QMS gap analyses, identify process weaknesses, and drive corrective and preventive action plans.
• Maintain and improve the Quality Manual, SOPs, work instructions, and related controlled documents across all departments.
• Lead internal audits and coordinate external/third-party audits; prepare audit responses and oversee closure of non-conformances.
• Foster a quality culture across the organization through training programmes and quality awareness initiatives.

2.  Regulatory Affairs & Certifications

• Manage and maintain regulatory submissions and product registrations with HSA (Singapore MDA) for IVD medical devices.
• Lead CE-IVD/IVDR compliance activities, including technical documentation, Declaration of Conformity, and liaison with Notified Bodies.
• Monitor changes to applicable regulations (ISO 13485, IVDR, HSA MDA, ASEAN AMDD) and assess impact on existing QMS and product registrations.
• Coordinate with external regulatory consultants and legal counsel on cross-border market access strategies in Southeast Asia and beyond.
• Support product development teams with regulatory input during design and development, risk management (ISO14971), and design verification/validation activities.
• Manage post-market surveillance activities including complaint handling, vigilance reporting, and periodic safety update reports.

3.  AI Integration in Quality Operations

• Identify and pilotAI-assisted tools for QMS functions including intelligent document management, automated non-conformance tracking, audit trail analysis, and regulatory intelligence monitoring.
• Collaborate with IT and bioinformatics teams to evaluate and deploy AI/ML solutions that improve quality data analysis, risk assessment, and complaint trending.
• Develop validation frameworks and procedures for AI tools used in quality-critical processes, ensuring compliance with applicable standards.
• Stay current with industry guidance on AI use in regulated medical device environments (e.g., FDA AI/ML guidance, IMDRF frameworks) and translate into internal policies.
• Champion responsible AI adoption within the quality function — balancing efficiency gains with regulatory traceability and auditability requirements.

4.  Supplier & Partner Quality

• Qualify and periodically audit critical suppliers and contract manufacturers; manage approved supplier lists.
• Review and negotiate Quality Agreements with suppliers, distributors, and contract service providers.
• Manage OEM partner quality interfaces, ensuring incoming product quality and supply chain compliance.

5.  Cross-functional Collaboration

• Partner with R&D, operations, sales, and commercial teams to embed quality requirements into new product introduction and product lifecycle management.
• Provide QA sign-off for batch releases, labelling reviews, and product changes.
• Represent the quality function at senior leadership level; produce quality KPI dashboards and trend reports.

Qualifications & Experience

Essential

• Bachelor's degree or higherin Life Sciences, Biomedical Engineering, Molecular Biology, or a relateddiscipline.
• Minimum 5 years of experiencein Quality Assurance/QMS roles within a regulated medical device or IVDenvironment.
• Demonstrated working knowledge of ISO 13485:2016 and hands-on experience maintaining or auditing a certified QMS.
• Practical experience with HSA (Singapore MDA) IVD product registration processes.
• Solid understanding of CE-IVD/IVDR requirements, technical file structure, and conformity assessment pathways.
• Proficiency in CAPA management, risk management (ISO 14971), and non-conformance investigation methodologies.
• Strong documentation skills with meticulous attention to detail.
• Excellent communicator with the ability to engage regulators, auditors, and internal stakeholders at all levels.

Preferred

• Postgraduate qualification in Regulatory Affairs, Quality Management, or equivalent.
• Certified Quality Auditor(CQA, IRCA, or equivalent) or ISO 13485 Lead Auditor certification.
• Experience in next-generationsequencing (NGS), molecular diagnostics, or genomics-based IVDs.
• Exposure to ASEAN regulatory frameworks (e.g., BFAD Philippines, NPRA Malaysia, TFDA Taiwan).
• Hands-on experience with AI/automation tools applied to quality or regulatory processes (e.g., AI-driven document review, intelligent CAPA platforms, regulatory intelligence software).
• Familiarity with electronic QMS (eQMS) platforms such as Veeva Vault QMS, Master Control, or Qualio.
• Experience in startup or scale-up environment with the ability to operate independently and build processes from limited infrastructure.

Core Competencies

• Regulatory Acumen — deep understanding of IVD regulatory frameworks and ability to translate requirements into actionable QMS controls.
• Analytical Thinking —data-driven approach to quality problem solving, root cause analysis, and trend identification.
• AI Curiosity &Adaptability — genuine interest in applying AI/ML tools to regulated quality environments, with a compliance-first mindset.
• Cross-functional Influence —ability to influence without authority across R&D, operations, and commercial teams.
• Ownership & Initiative —self-directed and proactive; comfortable operating in a fast-moving scale-up environment.
• Audit Readiness — confident representing the company during regulatory inspections and stakeholder briefings.