Quality Engineer (Medical Device industry)
We’re Hiring! Quality Engineer
Are you passionate about ensuring top-quality standards in Medical Products? We are looking for a highly skilled Quality Engineer to support our quality assurance processes and compliance with Malaysia MDA requirements.
Location: Oasis Square, Ara Damansara, Petaling Jaya, Selangor
Contract Duration: 12 months (renewable with PERSOLKELLY)
Working Days/Hours: Monday – Friday, 8:00 AM – 5:00 PM
Salary: RM6,000 – RM8,000 (based on experience & skills) + statutory contributions + leave entitlement + medical coverage
Key Responsibilities:
- Enhance Customer Satisfaction – Implement quality strategies to improve customer experience
- Quality System Leadership – Maintain and improve ISO 13485 QMS for Medical Devices & Cosmetics
- New Product & Change Qualification – Ensure all products meet customer, regulatory, and market requirements
- Quality Issue Resolution – Work closely with labs & plants to minimize lead times and resolve complaints
- Supplier Product Quality Management – Ensure outsourced products meet required standards
- Product Quality Support – Manage design follow-ups, sampling plans, and document revisions
What We’re Looking For:
- Bachelor’s degree or higher in Engineering or Science (STEM field preferred)
- Minimum 5 years of experience in the Medical Device industry
- Strong background in ISO 13485, GDPMD, and Malaysia MDA regulations
- Experience in Manufacturing, Quality, or Laboratory roles
- Certifications in Quality Engineering/Auditing (EOQ standard or similar) are a plus
- Proficient in Microsoft Office
How to Apply?
Send your resume to [email protected]
(Only shortlisted candidates will be contacted.)
#CWSA
Job Types: Full-time, Contract
Contract length: 12 months
Pay: RM6,000.00 - RM8,000.00 per month
Benefits:
- Health insurance
- Maternity leave
- Parental leave
- Professional development
Schedule:
- Monday to Friday
Application Question(s):
- How soon you can start work?
- Reason for leaving your current job
- Experience in Medical Device QMS – ISO 13485, MSAP, MDD, Malaysia MDA regulations?
Education:
- Bachelor's (Preferred)
Experience:
- Medical Device industry: 5 years (Preferred)
Location:
- Petaling Jaya (Preferred)