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.

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