Design Quality Engineer: FDA Remediation & Design Control

Katalyst-Healthcares-; SOUTH PLAINFIELD (NJ); Vor Ort; USD 90.000 - 140.000; Vollzeit

Zusammenfassung

Creative Solutions Services, LLC is seeking a Design Quality Engineer in New Jersey to support FDA remediation activities across design controls, product risk management, and quality system gaps. You will collaborate with Quality, R&D, Regulatory, and Manufacturing to remediate legacy documentation and strengthen design control processes throughout the product lifecycle.

The role requires hands-on DHF remediation, knowledge of ISO 14971, 21 CFR Part 820, and ISO 13485, with a track record of

Qualifikationen

• 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 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.

Aufgaben

• 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

Kenntnisse

Design quality engineering

Design controls

FDA remediation

DHF remediation

Risk management (ISO 14971)

V&V

Traceability

CAPA

Regulatory knowledge

Cross-functional collaboration

Ausbildung

Bachelor's degree in Engineering or Science

ISO 13485 knowledge

Jobbeschreibung

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