Component Qualification

Title: DQE with Component Qualification
Location: Raritan, NJ
Client: Ethicon Inc
Keywords: Medical Device - Design Control, ISO 13485, ISO 14971 and FDA 21 CFR Part 820, Design History Files (DHF), Component Qualification, Product Risk Management, IQ, OQ, PQ, TMV, MSA

JD:

• Hands-on experience in medical device design and development.
• Hands-on experience with FDA-regulated Design Controls, Change Controls, and New Product Development (NPD).
• Hands-on experience in Component Qualification and Process Validation activities.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 14971 Risk Management.
• Lead and maintain Risk Management Files including Hazard Analysis and FMEAs.
• Review and approve DHF deliverables and quality documentation.
• Review and approve verification, validation, and design transfer deliverables.
• Participate in Design Reviews to ensure quality, regulatory, and product requirements are met.
• Review and approve Component Qualification, IQ, OQ, PQ, TMV, and Gage R&R studies.
• Assess product, process, and supplier changes for quality and regulatory impact.
• Participate in CAPA, and nonconformance investigations.
• Analyze quality metrics and compliance trends to drive continuous improvement.
• Serve as a Design Quality SME during audits, inspections, and design reviews.