Senior Quality Engineer

We are urgently seeking a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing.

• 10+ years of Quality Engineering experience in medical device manufacturing.
• Strong experience with FDA-regulated environments & Quality Systems.
• Hands-on Technology/Product/Process/Manufacturing Transfers.
• Validation experience: IQ/OQ/PQ, TMV & Process Validation.
• FDA-compliant quality documentation.
• PFMEA, Control Plans, Nonconformance & CAPA.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820 & Risk Management.
• Customer complaint investigations & Root Cause Analysis.
• Manufacturing readiness, NPI & scale-up.
• Strong technical writing and documentation skills.
• Internal/external audit support preferred.
• Injection molding, assembly or contract manufacturing experience is a plus
• Bachelor's degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
• Lead and support Quality Engineering activities within FDA-regulated medical device manufacturing.
• Manage Technology, Product, Process, and Manufacturing Transfers.
• Develop and execute IQ/OQ/PQ, Test Method Validation (TMV), and Process Validation activities.
• Prepare and maintain FDA-compliant quality and validation documentation.
• Develop and maintain PFMEA, Control Plans, Risk Assessments, and quality plans.
• Investigate nonconformances, CAPA, customer complaints, and quality issues.
• Perform root cause analysis and implement effective corrective and preventive actions.
• Support New Product Introduction (NPI), manufacturing readiness, scale-up, and process improvements.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, GMP, and applicable risk management requirements.
• Support internal and external quality audits and regulatory inspections.
• Collaborate with Manufacturing, R&D, Operations, Regulatory, Suppliers, and cross-functional teams.
• Provide technical writing, quality documentation, and engineering support.
• Support manufacturing processes such as injection molding, assembly, and contract manufacturing, when applicable.