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

• 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