Design Quality Engineer

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