Senior Quality Assurance Engineer

Senior Quality Assurance Engineer (Design Assurance)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 and ResponsibilitiesConduct end-to-end DHF audit and gap assessment, including:Design & Development PlanUser NeedsDesign Inputs & OutputsDesign Verification & Validation (V&V)Risk Management Files (ISO 14971)Design Reviews and TraceabilityEvaluate traceability across DHF elements (Inputs ? Outputs ? V&V ? Risk)Identify missing, weak, or non-compliant documentationDeliver audit-defensible gap assessment reports with actionable remediation recommendationsAssess regulatory gaps versus procedural non-conformitiesWork with partially remediated or legacy DHFsEducation & ExperienceStrong 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 documentationExperience identifying regulatory compliance gapsSenior-level Quality or Regulatory professionalPrior experience as: DHF Auditor / ReviewerDesign Controls SMEQuality Engineer in FDA-regulated medical devicesAbility to work independently and communicate findings clearlyStrong documentation and report-writing skillsFocus is on analysis and gap identification, not document rewriting