Design Quality Engineer

Katalyst Healthcares and Life Sciences

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:

ssess 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
bility to independently identify compliance gaps and drive corrective actions cross-functionally.

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Vacancy posted 5 days ago

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