More jobs:
Senior Quality Systems Specialist remote
Remote / Online - Candidates ideally in
Singapore, Singapore
Listed on 2026-10-27
Singapore, Singapore
Listing for:
Artech Infosystems Private Limited
Remote/Work from Home
position Listed on 2026-10-27
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Medical Science
Job Description & How to Apply Below
Senior Quality Systems Specialist
Location: Singapore |
Work Type: Remote
Contract Duration: 12 Months
Job OverviewWe are looking for an experienced Senior Quality Systems Specialist to support Quality Management System (QMS) implementation, maintenance, and continuous improvement within the medical device industry. The role will focus on Singapore HSA regulatory compliance, ISO 13485 standards, and GDP/GDPMDS certification to support regional operations and commercialization.
The ideal candidate should have strong knowledge of Singapore medical device regulations and the ability to independently lead quality and certification initiatives.
Key Responsibilities- Implement, maintain, and improve ISO 13485-based Quality Management Systems.
- Lead and support GDP/GDPMDS certification and compliance activities.
- Ensure compliance with Singapore HSA medical device regulatory requirements.
- Coordinate with certification bodies, accreditation bodies, and regulatory authorities.
- Prepare and maintain quality documentation, procedures, and audit records.
- Collaborate with cross-functional teams to support certification and commercialization.
- Support regional quality system activities across Southeast Asia, including Malaysia where applicable.
- Bachelor's degree or higher in Life Sciences or a related discipline.
- 5–7 years of experience in Quality Assurance or Quality Systems within the medical device industry.
- Hands-on experience implementing or improving ISO 13485-based QMS.
- Strong knowledge of Singapore HSA regulatory requirements.
- Demonstrated experience supporting or leading GDP/GDPMDS certification projects.
- Proven track record in obtaining and maintaining GDP certification.
- Experience working with certification bodies, accreditation bodies, and regulatory authorities.
- Proficiency in Microsoft Office applications.
Preferred: Experience with medical device quality systems and regulatory requirements in Malaysia.
Contract: 12 months
Work Arrangement: Remote
Position Requirements
10+ Years
work experience
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