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Quality Engineer (Medical Devices)
On-site · Singapore, Singapore
Job Summary
Quality Engineer for medical devices responsible for ensuring regulatory compliance (ISO 13485, FDA QSR 21 CFR Part 820, GMP) and driving continuous improvement across product quality and manufacturing processes. Key duties include leading CAPA investigations, performing internal and supplier audits, reviewing DHF/DMR/DHR, participating in risk management (ISO 14971) with activities such as hazard analysis and FMEA, collaborating with R&D/manufacturing/regulatory teams on new product development and process validation, ensuring GMP compliance, handling NCRs, supporting IQ/OQ/PQ validation, and driving supplier quality management and data-driven improvement initiatives (Lean, Six Sigma). Required skills include strong knowledge of quality systems and regulatory requirements, CAPA, audits, validation, statistics (SPC), and excellent communication and analytical abilities.
Required Qualifications
- Bachelor’s degree in Engineering, Biomedical, Life Sciences, or related field
- 3–8 years of experience in quality engineering within the medical device/pharmaceutical/healthcare industry
- Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820
- ISO 14971 (Risk Management)
- GMP requirements
- Experience with CAPA, audits, validation, and document control systems
- Familiarity with statistical tools and quality methodologies (SPC, Six Sigma, Root Cause Analysis)
- Excellent problem-solving, analytical, and communication skills
Desired Qualifications
- Certified Quality Engineer (CQE) or Six Sigma Green Belt/Black Belt will added advantage
- Experience with sterile products, combination products, or Class II/III medical devices
- Knowledge of regulatory submissions (e.g., 510(k), CE Marking)
- Experience with electronic QMS systems
- Experience in supplier quality management
- Experience in HLA (and High Level Assembly Manufacturing) SMT (PCBA manufacturing)
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