Title:

DQE with

Component Qualification Location:

Raritan, NJ Job Description:

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 complaint trends to drive continuous improvement. Serve as a Design Quality SME during audits, inspections, and design reviews.

Pay:

From $40.00 per hour Expected hours: 40.0 per week

Work Location:

In person