Senior Quality Assurance Executive

4 days ago

Singapore LABGISTICS ASIA PTE LTD Full time

Overview:
This role is part of Labgistics Asia Pte Ltd's (LAA) Quality Assurance department under the Infrastructure Management Division. As a key member of the Quality Assurance team, the Senior Quality Assurance Executive reports to the Manager, Quality Assurance and Regulatory Affairs (QRA). The role focuses on the development and maintenance of the overall Quality Management System (QMS) of the company.
Key Responsibilities:
Implement both existing and new ISO 13485 and GxP regulations as well as any other relevant standards for the company’s Quality Management System (QMS) and maintain employees’ awareness of regulatory trends in the industry and implement necessary changes in QMS.
Attain new and maintain existing business licenses and certifications including but not limited to GDP, ISO 9001, ISO 13485, etc., and maintain business license and certification tracker.
Liaise with regulatory and certification bodies and internal stakeholders to ensure that QMS processes and activities, including sales, contract manufacturing, storage, and distribution of goods, are in compliance with local and, where applicable, international regulations, codes, and standards.
Develop procedures and maintain QMS documentation through effective document control and manage cross-functional documentation development, review, and revision.
Prepare and conduct Management reviews and follow up with action items for closure.
Conduct internal training on quality-related topics and QMS processes to relevant staff.
Review both customer and supplier quality agreements and handle tender enquiries where required.
Identify QMS process gaps and collaborate with internal stakeholders to implement solutions for resolution.
Provide monthly QA KPI and compliance reporting to management on business and manufacturing plant’s operations including cases of any non-conformance with ISO 13485 and GxP guidelines.
Ensure all aspects of product contract manufacturing, storage, and distribution are performed in accordance with regulatory requirements, local quality standards, and company regulations.
Establish, communicate, and implement an internal audit program and conduct audits, following up with stakeholders to ensure audit findings are closed.
Coordinate and manage external audits from customers, suppliers, and regulatory bodies.
Plan and conduct site inspections of sales, storage, and distribution facilities, including review of business processes and addressing process non-conformances where appropriate.
Handle and manage complaints, recalls, deviations, CAPA, incidents of counterfeiting and tampering, supplier performance, and other relevant quality performance measures, ensuring they are raised, investigated, reported, trended, and communicated to relevant stakeholders and management.
Track yearly quality-related KPIs and objectives and ensure necessary actions are taken to achieve KPI targets and follow up on any shortfalls.
Handle regulatory queries and assist in product registrations or permit applications where applicable.
Manage product registrations and business license tracker as required.
Qualifications:
Education:
Bachelor’s degree in quality management, life sciences, engineering, or a related field.
Experience:
Minimum of 3 years of QA experience in ISO 9001, ISO 13485, or GxP (e.g., Good Distribution Practice) for at least one of the preferred categories or equivalent, i.e., medical device, single-use devices, microbiology diagnostics, or a related industry.
Regulatory Knowledge:
Strong understanding of ISO 9001, 13485, GMP, GDP, and other relevant regulatory requirements. Experience with regulatory inspections and audits is essential. Lead auditor qualification in ISO 9001 and ISO 13485 is preferred.
Skills:
Strong analytical and problem-solving skills.
Excellent communication and leadership skills.
Familiarity with risk management principles and quality improvement methodologies.
Certifications:
Quality management certifications (e.g., Certified Quality Auditor - CQA, Certified Quality Manager - CQM) are a plus.
Only Singaporeans may apply.
Fluent in both written and oral English.
#J-18808-Ljbffr

  • Quality Assurance Executive

    2 weeks ago

    Singapore QUALITY MEAT PTE. LTD. Full time

    Roles & ResponsibilitiesJob ResponsibilitiesWork closely with all production team on the production process and oversee the day-to-day operations to ensure compliance with AVA, NEA HACCP guidelines and ISO standards Perform the creation and revision of corporate level quality documents that support GMP operations to ensure compliance with GMP guidelines ...

  • Senior Quality Assurance Executive

    5 days ago

    Singapore Recruit Express Services Pte Ltd Full time

    Senior Quality Assurance Executive:We are looking for a seasoned Senior Quality Assurance Executive to lead our quality management efforts. As a key member of our team, you will be responsible for establishing and maintaining QMS, SOP, and Work Instructions for the technical/quality department. Additionally, you will manage product non-conformance (NC) and...

  • Quality Assurance Executive

    4 days ago

    Singapore QUALITY MEAT PTE. LTD. Full time

    Job Responsibilities Work closely with all production team on the production process and oversee the day-to-day operations to ensure compliance with AVA, NEA HACCP guidelines and ISO standards. Perform the creation and revision of corporate level quality documents that support GMP operations to ensure compliance with GMP guidelines. Assist to contribute to...

  • Senior Quality Assurance Specialist

    6 days ago

    Singapore Bank Of America Full time

    Job Description:We are seeking a skilled Senior Quality Assurance Specialist to join our team at Bank of America. As a key member of our Quality Control project teams, you will play a critical role in ensuring that our applications and systems meet the highest standards of quality. Your primary responsibility will be to work closely with project teams to...

  • Senior Quality Assurance Professional

    5 days ago

    Singapore Alcon Full time

    We are seeking a talented Quality Assurance professional to join our team as a Senior Associate, Quality Assurance APAC.In this role, you will be responsible for ensuring operational processes align with Alcon quality requirements and regulatory specifications.You will also oversee regional quality teams, conduct inspections and evaluations, and facilitate...

  • Senior Assurance Manager

    5 days ago

    Singapore AAA ASSURANCE PAC Full time

    Job DescriptionWe are seeking an experienced Audit Manager to join our team in leading assurance engagements and executing complex audit procedures. Key responsibilities include:

  • Senior Quality Assurance Manager

    4 days ago

    Singapore Vanguard Software Pte Ltd Full time

    Job OverviewVanguard Software Pte Ltd is seeking an experienced Senior Quality Assurance Manager to lead our QA team in delivering high-quality gaming products. As a key member of our team, you will be responsible for ensuring the scalability and stability of our product through comprehensive testing.

  • Senior Quality Assurance Specialist

    4 days ago

    Singapore Instant Hire Full time

    Company Overview:Instant Hire is a dynamic company that offers exciting opportunities for professionals seeking to make a difference in the manufacturing industry. Our team is dedicated to excellence, and we are looking for talented individuals who share our passion for quality assurance.Salary and Benefits:Our compensation package includes a competitive...

  • Quality Assurance

    6 days ago

    Singapore RECRUITFLASH PTE. LTD. Full time

    Roles & ResponsibilitiesMNC FA Assistant Engineer/FA Engineer( QA inspector/First Article) Woodland / Yisun / 5 days work week / Good pay + Good Bonus FA/QA experience welcome apply Good Pay + Good Bonus / Permanent role / 5 days work week Full training provided for Junior / Permanent role / Junior Senior welcome Responsible for performing First Article...

  • QUALITY ASSURANCE ENGINEER

    2 weeks ago

    Singapore DECOR INDUSTRIES PTE LTD Full time

    Roles & Responsibilities Test current products and identifying deficiencies & Suggest solutions to identified product problems Investigate product quality in order to make improvements to achieve better customer satisfaction Plan Create and manage the overall Quality Planning strategy Collaborate with the Product Development team to ensure...

  • Advanced Quality Assurance Executive

    5 days ago

    Singapore GSK Full time

    We're looking for a talented Quality Assurance Executive to join our team at GSK.As a Quality Assurance Executive, you will be responsible for managing the interactions with third-party organisations that supply QA incoming materials and/or services to GSK.You will manage material release for incoming materials, supplier change notifications, and new...

  • Quality Assurance

    3 weeks ago

    Singapore RECRUITFLASH PTE. LTD. Full time

    Roles & ResponsibilitiesMNC FA Technician /QA Engineer ( QA inspector/First Article ) Woodlands / Yisun / 5 days work week / Good pay + Good BonusFA/QA experience welcome apply Full training provided for Junior / Permanent role / Junior Senior welcome Carry out QA Inspection (First ArticleRecord inspection resultin charge FA result documentation &...

  • Quality Assurance

    2 weeks ago

    Singapore RECRUITFLASH PTE. LTD. Full time

    Roles & ResponsibilitiesMNC FA Technician /QA Engineer ( QA inspector/First Article ) Woodlands / Yisun / 5 days work week / Good pay + Good BonusFA/QA experience welcome apply Full training provided for Junior / Permanent role / Junior Senior welcome Carry out QA Inspection (First ArticleRecord inspection resultin charge FA result documentation &...

  • Senior Quality Assurance Director

    5 days ago

    Singapore Merck Gruppe Full time

    Job Overview:Merck Gruppe seeks a skilled Senior Quality Assurance Director to promote and integrate quality into every aspect of our business. As the head of the QA department, you will be responsible for ensuring compliance with sound scientific practice, Gx P, and standard operating procedures.You will lead a team performing data audits, internal...

  • Quality Assurance Executive

    2 weeks ago

    Singapore WECRUIT PTE. LTD. Full time

    Roles & ResponsibilitiesGeneral ResponsibilitiesEnsure that all services provided by the centres meet or exceed internal standards and quality assurance guidelines. Conduct audits to ensure regulatory compliance, reviewing internal processes and procedures, and identifying high-risk non-compliance areas in line with regulatory standards. Participate in...

  • Quality Assurance Specialist

    4 days ago

    Singapore 605 Marina Bay Sands Pte Ltd Full time

    About 605 Marina Bay Sands Pte LtdWe are a leading hospitality company dedicated to delivering exceptional guest experiences.Job DescriptionThe Assistant Manager, Hotel Training & Quality Assurance is responsible for executing evaluations, managing evaluation tasks, and upholding professional discretion. The role also involves quality assurance analysis,...

  • Quality Assurance

    3 weeks ago

    Singapore RECRUITFLASH PTE. LTD. Full time

    Roles & ResponsibilitiesMNC FA Technician /QA Engineer ( QA inspector/First Article ) Woodlands / Yisun / 5 days work week / Good pay + Good BonusFA/QA experience welcome apply Full training provided for Junior / Permanent role / Junior Senior welcome Carry out QA Inspection (First ArticleRecord inspection resultin charge FA result documentation &...

  • Quality Assurance

    3 weeks ago

    Singapore RECRUITFLASH PTE. LTD. Full time

    Roles & ResponsibilitiesMNC FA Technician /QA Engineer ( QA inspector/First Article ) Woodlands / Yisun / 5 days work week / Good pay + Good BonusFA/QA experience welcome apply Full training provided for Junior / Permanent role / Junior Senior welcome Carry out QA Inspection (First ArticleRecord inspection resultin charge FA result documentation &...

  • Senior Quality Assurance Specialist

    4 days ago

    Singapore Merck Gruppe - MSD Sharp & Dohme Full time

    We are seeking a highly skilled and motivated Senior Quality Assurance Specialist to join our team at Merck Gruppe - MSD Sharp & Dohme. As a key member of our quality team, you will be responsible for ensuring that all laboratory procedures are conducted in accordance with established standards and regulatory requirements.The successful candidate will have a...

  • Quality Assurance Specialist

    5 days ago

    Singapore 605 Marina Bay Sands Pte Ltd Full time

    About the RoleWe are seeking an experienced quality assurance specialist to join our team at Marina Bay Sands. As Assistant Manager, Hotel Training & Quality Assurance, you will be responsible for executing evaluations, planning and managing evaluation tasks, and upholding professional discretion during evaluations.You will work closely with the hotel's...