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 [Confidential Information]
