Job description: Quality Systems Manager
Company: Genesis Medtech International
Location: Singapore
Job Type: Full-time
Salary Range: SGD 7,000 – 10,000/month
Professional Job Description
We are seeking a Quality Systems Manager to lead the implementation, maintenance, and continuous improvement of the company’s Quality Management System (QMS). You will ensure full compliance with Singapore regulatory requirements and global quality standards, supporting quality systems across the product lifecycle in the surgical/medical device business.
Key Responsibilities
- Develop, implement, and maintain core Quality Systems including CAPA, Nonconformance, Change Control, Document Management, Training, Quality Agreements, and Complaint Handling.
- Ensure QMS documentation and records are accurate, controlled, and audit-ready.
- Drive continuous improvement of quality processes and tools across international markets.
- Support regulatory compliance (ISO 13485, GDPMDS, MDSAP, EU MDR, FDA 21 CFR Part 820, and related standards).
- Collaborate with cross-functional teams to deploy and sustain effective quality systems.
- Prepare for and support internal/external audits and regulatory inspections.
- Monitor quality metrics and drive corrective and preventive actions.
Requirements & Qualifications
- Education: Bachelor’s degree in Engineering, Science, or a related field.
- Experience: Minimum 6 years in medical devices, MedTech, or other regulated industries, with strong QMS experience.
- Technical Skills: Solid working knowledge of ISO 13485, GDPMDS (SS620), MDSAP, EU MDR, FDA QSR, GMP/GDP/GLP.
- Soft Skills: Strong leadership, analytical, communication, and stakeholder management abilities.
- Other: Experience in regulated manufacturing environments and audit readiness is preferred.
How to Apply
Please submit your updated resume through Indeed. Candidates who meet the job-related requirements will be contacted for the next stage of the recruitment process.
Pay: $7,000.00 - $10,000.00 per month
Benefits:
- Flexible schedule
- Health insurance
Work Location: Hybrid remote in Singapore 118227