Summary: Our client is a medical device manufacturer seeking a Design Quality Engineer to support FDA remediation activities across design controls, product risk management, and quality system gaps. This individual will partner with Quality, R&D, Regulatory, and Manufacturing to assess and remediate legacy documentation, strengthen design control processes, and ensure risk management requirements are integrated throughout the product lifecycle.
Roles & Responsibilities:- Assess and remediate gaps within Design History Files and design control documentation including design inputs, outputs, design reviews, traceability, V&V, design changes, and design transfer
- Ensure appropriate linkage and traceability between design requirements, risk management files, V&V, complaints, CAPA, and change control
- Review engineering and design changes for appropriate Design Quality impact assessment, documentation, and regulatory consideration
- Support product risk management remediation per ISO 14971 including hazard analyses, risk assessments, risk controls, benefit-risk evaluations, and residual risk documentation
- Review and remediate legacy risk management documentation including gaps in objective evidence, traceability, and lifecycle documentation
- Support remediation activities resulting from FDA observations, inspections, audits, and regulatory commitments
- Support CAPA activities related to design controls, product development, and risk management
- Ensure DHF and risk management documentation is complete, traceable, and inspection-ready
- Partner cross-functionally with Engineering, Quality, Regulatory, and Manufacturing SMEs to investigate compliance gaps and drive remediation to closure
Education & Experience: - Strong medical device Design Quality Engineering experience including design controls and product development
- Hands-on DHF remediation and FDA compliance remediation experience
- Strong knowledge of design inputs/outputs, design reviews, traceability, V&V, design transfer, and design changes
- ISO 14971 and product risk management experience including hazard analysis and risk controls
- 21 CFR Part 820 and ISO 13485 knowledge
- Experience supporting FDA 483, Warning Letter, or Health Authority observation remediation preferred
- Ability to independently identify compliance gaps and drive corrective actions cross-functionally
