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:

Design Controls & DHF Remediation:

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 considerations

Risk Management:

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

FDA Remediation & Compliance:

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.