Production Quality Engineer (Medical Device)

Key Responsibilities Nonconformance & CAPA Management — Lead investigations for product or process non‑conformances, perform structured root‑cause analysis (5 Whys, Fishbone, FMEA), and implement effective corrective and preventive actions. Process Validation — Support and execute validation activities (IQ/OQ/PQ) for equipment, manufacturing processes, and test methods. Production Quality Support — Work closely with Production team to maintain product conformity, ensure documentation accuracy, and uphold Good Manufacturing Practices. And Support Production in failure, data and root cause analysis Continuous Improvement — Drive initiatives to reduce defects, improve yield, strengthen operator awareness, and support Lean/Kaizen activities. Audit Participation — Contribute to internal audits and support external audits conducted by customers, notified bodies, and regulatory authorities. Quality Reporting — Prepare quality metrics, trend analyses, and reports for management review. Risk Management — Ensure compliance with ISO 14971 risk management processes and support risk‑based decision making across production activities. Requirements Diploma or Degree in Engineering (Mechanical, Biomedical, Manufacturing, or related field). Minimum 2–5 years of experience in medical device manufacturing or other regulated industries. Strong understanding of ISO 13485, GMP, and FDA QMSR (21 CFR Part 820) requirements. Experience with validation protocols, statistical analysis, and quality tools (SPC, MSA, FMEA). Excellent analytical, problem‑solving, and communication skills. Advantageous: Experience with customer audits, supplier quality, or Lean/Six Sigma certifications. Send your resume to linda@forteemp.com.sg