Senior Quality Assurance Engineer
Katalyst Healthcares and Life Sciences, Mundelein, IL, United States
Job Summary :
The Senior Quality Assurance Engineer (Design Assurance) is responsible for providing oversight and governance of Design History Files (DHF) to ensure compliance with regulatory standards and internal quality requirements.This role plays a key part in guiding design controls, facilitating design transfer, and managing risk documentation across medical device product lines (Class I and Class II 510(k)). The engineer will ensure that all processes and documentation meet FDA and ISO standards, and that design changes are properly controlled and documented.
Roles & Responsibilities :
Conduct end-to-end DHF audit and gap assessment , including:
Design & Development Plan
User Needs
Design Inputs & Outputs
Design Verification & Validation (V&V)
Risk Management Files (ISO 14971)
Design Reviews and Traceability
Evaluate traceability across DHF elements (Inputs → Outputs → V&V → Risk)
Identify missing, weak, or non-compliant documentation
Deliver audit-defensible gap assessment reports with actionable remediation recommendations
Assess regulatory gaps versus procedural non-conformities
Work with partially remediated or legacy DHFs
Education & Experience :
Strong expertise in Medical Device Design Controls (21 CFR 820.30, ISO 13485)
Hands-on experience in reviewing and auditing DHFs (not just document authoring)
In-depth knowledge of ISO 14971 risk management (hazards, controls, residual risk)
Experience supporting DHF remediation in response to:
Strong ability to assess traceability and consistency across documentation
Experience identifying regulatory compliance gaps
Senior-level Quality or Regulatory professional
Prior experience as: DHF Auditor / Reviewer
Design Controls SME
Quality Engineer in FDA-regulated medical devices
Ability to work independently and communicate findings clearly
Strong documentation and report-writing skills
Focus is on analysis and gap identification , not document rewriting
The Senior Quality Assurance Engineer (Design Assurance) is responsible for providing oversight and governance of Design History Files (DHF) to ensure compliance with regulatory standards and internal quality requirements.This role plays a key part in guiding design controls, facilitating design transfer, and managing risk documentation across medical device product lines (Class I and Class II 510(k)). The engineer will ensure that all processes and documentation meet FDA and ISO standards, and that design changes are properly controlled and documented.
Roles & Responsibilities :
Conduct end-to-end DHF audit and gap assessment , including:
Design & Development Plan
User Needs
Design Inputs & Outputs
Design Verification & Validation (V&V)
Risk Management Files (ISO 14971)
Design Reviews and Traceability
Evaluate traceability across DHF elements (Inputs → Outputs → V&V → Risk)
Identify missing, weak, or non-compliant documentation
Deliver audit-defensible gap assessment reports with actionable remediation recommendations
Assess regulatory gaps versus procedural non-conformities
Work with partially remediated or legacy DHFs
Education & Experience :
Strong expertise in Medical Device Design Controls (21 CFR 820.30, ISO 13485)
Hands-on experience in reviewing and auditing DHFs (not just document authoring)
In-depth knowledge of ISO 14971 risk management (hazards, controls, residual risk)
Experience supporting DHF remediation in response to:
Strong ability to assess traceability and consistency across documentation
Experience identifying regulatory compliance gaps
Senior-level Quality or Regulatory professional
Prior experience as: DHF Auditor / Reviewer
Design Controls SME
Quality Engineer in FDA-regulated medical devices
Ability to work independently and communicate findings clearly
Strong documentation and report-writing skills
Focus is on analysis and gap identification , not document rewriting