Auditing, Code of Federal Regulations, Communication Skills, Design Verification, Document Management, Documentation, FDA (Food and Drug Administration), Gap Analysis, ISO (International Organization for Standardization), Internal Audit, Maintain Compliance, Medical Equipment, Medical Products, Quality Assurance, Quality Engineering, Regulations, Regulatory Compliance, Risk, Risk Management, Traceability, Validation Testing
- 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.
- The primary focus of this engagement is to support a DHF gap analysis initiative within the client's medical device portfolio. The ideal candidate will be an audit-ready professional capable of independently evaluating DHF completeness and compliance.
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
Requirements:
- 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:
- FDA inspections
- CAPAs
- Notified Body audits or internal audits
- 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
- Remote work allowed after initial training period
- Must be available for onsite training (minimum 2 weeks)