Total 36 quality manager job vacancies in Quality Assurance / Control category in Johor Bahru, Johor

Job Responsibilities:

1. New product registration:

• Prepare and compile registration dossiers in accordance with relevant regulatory requirements including: 
  

  • Constructing/ editing letters of response/ justification/ declaration and clinical documentation for submission packages in accordance with guidelines checklists.

  • Compile/ review/check material for dossier prior to submission, incorporate feedback from relevant stakeholders.

  • Conduct checks on artworks to ensure in compliance with local regulation.

• Submit product registration applications to local health authorities  according to target submission timelines.
• Liase with and respond to additional requests or queries from health authorities and follow up (when necessary) until approval per target timelines.
• Liase with enternal and external stakeholders/ departments to build rapport and to achieve target outcomes.

2. Comply with regulatory requirements: to maintain validity of existing licenses/ certification/ authorization (e.g, product licenses, manufacturing licenses, establishment license, GDPMD licenses, import/ export license) through timely variations and/ or renewals to ensure supply continuity.

3. Keep abreast of regulatory updates from health authorities in the drugs, cosmetics, and medical device space.

• Assess regulatory updates on impact to business and communicate insights on approach to handle affairs.
• Propose solutions to arising issues.

4. Update and maintain database of regulatory and product registration information.

5. Good maintenance of final submitted documentation and local repository.

6. Ensure compliance with quality procedures stipulated for regulatory affairs, its administartive maintenance, and plan/ suggest improvements to operations.

7. Support any audits or inspections.

8. Guide/ oversee work performance and development of direct report.

9. Provide input for periodic operation metrics/ budget initiatives by managing  operating expenses within approved budget for the year.

10. Handle any other assingment as advised by supervisor.

Requirements: 

• Possess a Bachelor Science
• Work experience in regulatory affairs.
• Familiar with drugs/ cosmetics/ medical device regulatory landscape and GxP related matters.
• Proficiency in Microsoft Office Applications and relevant regulatory system software.
• Adopt good practices in documentation and communication.

Perks & Benefits

• Allowance ( mileage,transportation)
• Medical insurance

工作職責：

1、新產品註冊：

• 根據相關監管要求準備和編制註冊檔案，包括：
  

  • 根據指南清單建立/編輯提交包的回應/理由/聲明和臨床文件。

  • 在提交之前編譯/審查/檢查檔案資料，納入相關利害關係人的回饋。

  • 對藝術品進行檢查，以確保符合當地法規。

• 根據目標提交時間表向當地衛生部門提交產品註冊申請。
• 與衛生當局聯絡並回應其他請求或詢問，並跟進（必要時）直至按照目標時間表獲得批准。
• 與內部和外部利害關係人/部門聯絡，建立融洽關係並實現目標成果。

2. 遵守監管要求：透過及時變更和/或更新來維持現有許可證/認證/授權（例如產品許可證、製造許可證、企業許可證、GDPMD許可證、進出口許可證）的有效性，以確保供應連續性。

3. 隨時了解衛生當局在藥品、化妝品和醫療器材領域的最新監管動態。

• 評估監管更新對業務的影響，並就處理事務的方法傳達見解。
• 針對出現的問題提出解決方案。

4.更新和維護監管和產品註冊資訊資料庫。

5. 妥善維護最終提交的文件和本機儲存庫。

6. 確保遵守監管事務、行政維護規定的品質程序，並規劃/建議營運改善。

7. 支持任何審計或檢查。

8. 指導/監督工作績效和直接報告的發展。

9. 透過在年度核准的預算內管理營運費用，為定期營運指標/預算計畫提供輸入。

10. 處理主管建議的任何其他分配。

要求：

• 擁有科學學士學位
• 監管事務方面的工作經驗。
• 熟悉藥品/化妝品/醫療器材監管環境和 GxP 相關事宜。
• 熟練Microsoft Office應用程式和相關監管系統軟體。
• 在文件和溝通方面採用良好的做法。

津貼和福利

• 津貼（里程、交通）
• 醫療保險

✔ Quality Engineer (Assembly Test)

✔ Gelang Patah, Johor Bahru

✔ Optical product manufacturer

✔ Monday - Friday

✔ 8.00am - 5.30pm

✔ Min Degree in Optics, Materials Science, Mechanical Engineering or any related field

✔ Min 5 years of working experience in manufacturing environment and handling QA systems, processes and audit

✔ Basic salary can be up to RM7000

Job Responsibilities :

• Conduct thorough inspections of optical components, lenses, metal barrels, and related materials
• Utilize specialized testing equipment to verify optical characteristics
• Monitor the assembly process to identify any deviations from established procedures or specifications, ensuring correct alignment and mounting
• Conduct interferometric tests to assess the surface quality and shape of optical components
• Perform final inspections on completed optical systems with metal barrels to ensure they meet all specified quality requirements

Requirements :

• Min Degree in Optics, Materials Science, Mechanical Engineering or any related field
• Min 5 years of working experience in manufacturing environment and handling QA systems, processes and audit
• Have experience in QA within optical lens assembly with metal components
• Knowledgeable in optics principles, lens manufacturing processes, and optical testing techniques
• Proficient in handling precision measurement tools, and metal testing equipment
• Proficient in using quality management software and tools
• Willing to travel for the audit suppliers
• Relevant certifications in optics, metallurgy, or quality assurance (ASQ Certified Quality Engineer, Optical Society of America certifications) is an added advantage

Benefits :

• Quarterly bonus
• Flexi bonus
• AWS
• Salary increment

✔ 品質工程師（組裝測試）

✔ 振林山, 新山

✔ 光學產品製造商

✔ 週一至週五

✔ 上午 8.00 至下午 5.30

✔ 光學、材料科學、機械工程或任何相關領域的最低學位

✔ 至少 5 年製造環境和處理 QA 系統、流程和審核的工作經驗

✔ 底薪可達 RM7000

工作職責 ：

• 對光學元件、鏡頭、金屬鏡筒和相關材料進行徹底檢查
• 利用專業測試設備驗證光學特性
• 監控組裝過程，識別與既定程序或規範的任何偏差，確保正確對齊和安裝
• 進行干涉測試以評估光學元件的表面品質和形狀
• 對帶有金屬鏡筒的完整光學系統進行最終檢查，以確保它們符合所有指定的品質要求

要求 ：

• 光學、材料科學、機械工程或任何相關領域的最低學位
• 至少5 年製造環境以及處理 QA 系統、流程和審核方面的工作經驗
• 具備金屬零件光學鏡片組裝品質保證經驗
• 熟悉光學原理、鏡頭製造流程和光學測試技術
• 熟練操作精密測量工具、金屬檢測設備
• 熟練使用品質管理軟體和工具
• 願意為審核供應商出差
• 光學、冶金或品質保證的相關認證（ASQ 認證品質工程師、美國光學協會認證）是額外優勢

好處 ：

• 季度獎金
• 靈活獎金
• AWS
• 加薪

Key Responsibilities

• Ensuring a consistently high-quality experience for end-users.
• Leading a team to oversee quality activities in assigned markets.
• Monitoring and ensuring quality and regulatory compliance of external manufacturers and distributors, including the identification and resolution of non-compliance.
• Oversee new product introduction and supplier qualification, ensuring continued quality compliance of partners.
• Maintain QMS alignment with international standards, health authorities, regulatory guidelines, and company standards.
• Perform batch release in respective markets to ensure compliance with GMP and regulatory requirements.
• Ensure change controls, deviations, CAPA management, recall activities are managed timely and effectively.
• Oversee new product introduction and supplier qualification process.

Requirements

• Bachelors in Science (or a related discipline).
• At least 10 years' experience in the life science industry (e.g. pharmaceuticals, medical devices, and health supplements) in the quality function with strong technical knowledge in GxP.
• Experience leading teams and quality improvement projects.
• Strong business acumen, problem-solving capabilities, communication skills and stakeholder management are important for this position.

To apply, submit your most updated resume showcasing relevant qualifications and experience.

Not the right opportunity?

We're always looking out for the best talents in the life science industry. If you are currently seeking exciting opportunities within the pharmaceuticals, medical devices, in-vitro diagnostics (IVD), or consumer health industry, do reach out for a confidential chat.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

I am presently representing a company in their search for a Quality Assurance Leader to bolster their ambitious business expansion endeavors. The selected candidate will be entrusted with spearheading a team of QA professionals to bolster the company's achievements and successes.

MAIN RESPONSIBILITIES

1. Team Leadership:

• Strategizing, leading, and overseeing the operations of the QA group.
• Fostering a collaborative relationship between QA team members and other functional departments achieve business success
• Oversee the productivity of the QA team and develop tailored progression plans for QA executives.

2. Driving change and transformation:

• Directing the regional quality operations team, ensuring its pivotal role in meeting business goals through a risk-oriented and efficient manner.
• Identifying ongoing enhancement prospects throughout the QMS and setting clear objectives for the regional QA team.

3. Collaboration and Stakeholder Engagement:

• Ensure effective cross-functional collaboration to fulfill quality needs for assigned regions.
• Partnering with diverse functional leaders to effectively drive business outcomes.

4. Operational Success

• Oversee new product introduction and supplier qualification/management, ensuring continued quality compliance of partners.
• Maintainence of Quality Management Systems and ensuring up-to-date compliance in accordance to relevant guidelines, regulatation and company policies.
• Ensure batch release/change controls/deviations/CAPA management/recall activities are being managed timely and effectively.

To apply, submit your most updated resume showcasing relevant qualifications and experience.

Requirements

• Bachelor's degree in Science or a related field.
• Minimum of 12-15 years' experience in the life science industry (such as pharmaceuticals, medical devices, and health supplements) within the quality function, demonstrating robust technical expertise in GxP.
• Proven experience in leading teams and driving quality improvement initiatives.
• Possession of strong business acumen, adept problem-solving skills, effective communication abilities, and adept stakeholder management capabilities are essential attributes for this role.

Not the right opportunity?

We're always looking out for the best talents in the life science industry. If you are currently seeking exciting opportunities within the pharmaceuticals, medical devices, in-vitro diagnostics (IVD), or consumer health industry, do reach out for a confidential chat.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

You will report to the Assistant Director and Director in the management, monitoring and validation of cardiac-related clinical data. You are responsible for collecting, coordinating and processing, as well as ensuring quality control of these data.

You will provide oversight for quality assurance activities and evaluate the effectiveness of the quality assurance programmes. You will manage the team through data validation and management exercise according to the Ensure Safer Systems’ requirements.

You will manage and facilitate value-based (VDC) projects with internal and external stakeholders, which includes overseeing the functions of the value driven care committee such as collecting and analysing data, developing methodology for measuring clinical quality indicators, and working with domain heads on interventions to mitigate the clinical quality performance trends. You will render support in audits and licensing requirements by the Ministry of Health. You will also promote and encourage staff participation in quality improvement programmes through providing project consultancy and leading the team in case analysis and following up on areas for improvement.

You are required to integrate and analyse data using statistical methods, perform analysis and work with teams to coordinate projects assigned. You will also coordinate meetings and document its proceedings, prepare reports, and participate in the implementation of improvement initiatives towards enhancing patient care.

You are responsible to lead and mentor team members as well as afoster good communication and teamwork within the department.

The selected candidate will be offered employment on 2-year renewable contractual terms.

Job Requirements:

· Recognised degree in health science, allied health or nursing with at least 4 years’ relevant experience in a healthcare industry

· Experience in benchmarking and statistical tools and techniques, and knowledge in improvement methodology tools and techniques

· Proficient in Tableau would be an advantage

· Proficient in Microsoft Office applications

· Able to work independently with strong analytical, problem-solving and organisational skills, and a good eye for detail

· Good oral and written communication skills

You will collaborate with stakeholders on timely data submissions and accurate reporting of clinical quality indicator results. This involves data extraction and analysis, and maintaining the department’s database. You will also promote and encourage staff participation in quality improvement programmes and contribute to projects relating to Quality Improvement initiatives.

In addition, you will coordinate and support Ensure Safe System (ESS) for Quality Assurance & Risk Management and liaise with ESS stakeholders to ensure standards are met. You will also coordinate meetings, prepare meeting minutes and reports, and provide any other administrative support. You will also work closely with internal/external stakeholders to support corporate programmes and participate in ad hoc operational projects and initiatives.

The selected candidate will be offered employment on 2-year renewable contractual terms.

Job Requirements:

· Degree in Biological Science or Applied Science, with 2 years’ working experience

· Proficient in Microsoft Office applications

· Excellent interpersonal, written and oral communication skills

· Meticulous with good organisational skills and able to work independently

You will support the administration of risk management programmes, conduct clinical review of patient records, identify relevant clinical care issues, and liaise with the respective departments to evaluate the effectiveness of the quality assurance programmes. You will play a supporting role in ensuring that clinical outcomes are consistent with current accepted practices.

You will be required to integrate and analyse data using statistical methods, perform root cause analysis, conduct risk mitigation exercises and work with teams to coordinate projects assigned. You will also coordinate meetings, document meeting proceedings, prepare reports and participate in the implementation of improvement initiatives towards improving patient care.

The selected candidate will be offered employment on 2-year renewable contractual terms.

Job Requirements:

· Recognised degree in health science, allied health or nursing

· Relevant experience in clinical quality and in the healthcare industry will be of added advantage

· Proficient in Microsoft Office applications

· Able to work independently with strong analytical, problem-solving and organisational skills, and a good eye for detail is essential

· Good oral and written communication skills

Quality Assurance & Quality Control Engineer (QA/QC Engineer)

Requirements:

• Recognized Diploma/Degree in related field
• Experience in working with Contractors
• Relevant experience in Civil/Building, preferably with experience in façade installation works
• Good team player and adaptable to a dynamic environment

Responsibilities:-

• To lead the QA/QC team
• To provide training and coaching to the team members in façade related works.
• To assess each construction process and procedure. Provide feedback and continuous improvement whenevee necessary
• To ensure internal quality controls are in place and being maintained properly
• Work closely with other project personnel such as production and site management team to deliver high quality works
• Prepare monthly analysis and report to Management in regards to site and project activities

Responsibilities:

• Test planning including batch planning.
• Extensive test coordination with various business departments and project team.
• Ability to manage business testing expectations and correct mindset (shift left instead of test everything).
• Work closely with business users, project team (Technical Product Owners and BA), Regional project team, Form Factory Dev, Report Dev and other team impacted.
• Good understanding of business backend processes, particularly in Distribution, Operations, Finance, Compliance etc.
• Good understanding of current state in terms of applications, architecture and data flow; for better understanding of upstream and downstream integrations.
• Lead triage and initial troubleshooting, with ability to quickly analyse issues and work closely with BA and Developers in prioritizing fixes.
• Have sense of urgency and ability to escalate potential risks/issues early, and holding other stakeholders accountable.
• Good knowledge on using JIRA and Confluence, responsible in pushing UAT testers to adopt JIRA as single tool of updating testing execution, defects and artifacts.
• Confluence will be used for project collaboration and UAT report update.
• Regular status update to PMO and stakeholders.

Lucence is an international genomic medicine company focusing on personalizing cancer care through novel tests for cancer detection and treatment. We are headquartered in Singapore with offices in Hong Kong, Suzhou and San Francisco.

Learning Outcomes

Interns will gain insight into the inner workings of the company’s Quality Management System (QMS) and develop an understanding of the regulatory frameworks established by the Ministry of Health (MOH) and the College of American Pathologists (CAP). Additionally, interns will become familiar with various tools utilized in our QMS for managing documents, records, and deviations from protocol. Lastly, interns will have the opportunity to learn about diagnostic laboratory operations.

Some of the key areas you will be involved in include:

· Managing and improving QMS in compliance with MOH, CLIA and CAP standards.

· Assisting in audit preparation involving all aspects of the clinical laboratory.

· Providing support in marketing, operations, logistics, and administrative functions as required.

· Assist the Quality Manager in duties such as the preparation of quality management reviews, external quality assurance, customer service surveys, and risk assessment and management.

To be a good fit for this role, you would have:

· Familiarity with quality management and quality control processes

· Good understanding of molecular diagnostics, especially cancer genetics, will be an advantage

· Ability to work well independently as well as in a team and have attention to detail and desire to improve current systems.

Please send your CV to hr@lucence.com indicating the position you are applying for in the subject line. In addition, get creative and tell us in the email in less than 100 words (in any language you like) why you think you will be a right fit for Lucence. Don't limit yourself to a job description or job title, the world needs every skill you have.

Job Description for Quality Assurance Engineer

· Conduct regular quality testing/evaluation to rectify and fix any issues related to product functionality.

· Work closely with R&D for the new product/part evaluation and generate quality evaluation report after evaluation.

· Conduct multiple types of testing, including functional, performance, reliability.

· Coordinating internal audit program for ISO 9001.

· Any ad hoc jobs as assigned by the team leader.

Qualifications

· Diploma / Degree in Mechatronics / Electrical / Electronic Engineering

· Minimum of 2 -5 years’ experience conduct ISO 9001 internal audit.

· In depth knowledge in ISO standard are highly recommended.

Requirements

· Ability to work independently and within a team environment.

· Analytical mind and problem-solving attitude.

Key Responsibilities:

• Review quality of products including all incoming shipments.
• Check and verify retail and customers' complaints.
• Prepare monthly retail complaint report for the Management.
• Handle local and overseas customers' product warranty & repairs issues via phone call and/or emails.
• Fixing and repair minor defects of products.
• Prepare document for customer service items to be delivered to suppliers and factories.
• Prepare document for customer service items to return to retail store.
• Order special orchids for production in factory.
• Source new orchids for development.
• Prepare reports for the QC inspection.
• Assist Product Team to source for components of products.
• Perform any other tasks as and when assigned.

Job Requirement:

• Preferably with 1–2 years of experience in similar capacity
• A hands-on, resourceful and result oriented
• Ability to work well in a team
• Meticulous and able to meet tight deadlines
• Proficiency in Microsoft office
• Excellent organisational, presentation and interpersonal skills

You will report to the Assistant Director and Director in the management, monitoring and validation of cardiac-related clinical data. You are responsible for collecting, coordinating and processing, as well as ensuring quality control of these data.

You will provide oversight for quality assurance activities and evaluate the effectiveness of the quality assurance programmes. You will manage the team through data validation and management exercise according to the Ensure Safer Systems’ requirements.

You will manage and facilitate value-based (VDC) projects with internal and external stakeholders, which includes overseeing the functions of the value driven care committee such as collecting and analysing data, developing methodology for measuring clinical quality indicators, and working with domain heads on interventions to mitigate the clinical quality performance trends. You will render support in audits and licensing requirements by the Ministry of Health. You will also promote and encourage staff participation in quality improvement programmes through providing project consultancy and leading the team in case analysis and following up on areas for improvement.

You are required to integrate and analyse data using statistical methods, perform analysis and work with teams to coordinate projects assigned. You will also coordinate meetings and document its proceedings, prepare reports, and participate in the implementation of improvement initiatives towards enhancing patient care.

You are responsible to lead and mentor team members as well as afoster good communication and teamwork within the department.

The selected candidate will be offered employment on 2-year renewable contractual terms.

Job Requirements:

· Recognised degree in health science, allied health or nursing with at least 4 years’ relevant experience in a healthcare industry

· Experience in benchmarking and statistical tools and techniques, and knowledge in improvement methodology tools and techniques

· Proficient in Tableau would be an advantage

· Proficient in Microsoft Office applications

· Able to work independently with strong analytical, problem-solving and organisational skills, and a good eye for detail

· Good oral and written communication skills