Principal Design Quality Assurance Engineer

• Assure product and process quality in accordance with QMS & applicable regulations & quality principles.
• Ensure product development processes comply with ISO 13485, FDA 21 CFR Part 820, ISO 14971, ISO 10993-1, IEC 60601-1, IEC 62304, IEC 62366 and other applicable regulations or standards.
• Serve as the primary quality representative for product development teams.
• Lead design quality assurance activities throughout the product lifecycle – from concept, development, verification/validation, to commercialization.
• Lead or support risk management activities (e.g., FMEA, hazard analysis) throughout the product lifecycle. Develop risk management strategies and ensure that risk management documentation is up-to-date and in compliance with regulatory requirements.
• Lead or support investigations, root cause analysis, and continuous improvement initiatives related to product design.
• Ensure accurate, detailed, and compliant documentation related to design control processes. Review and approve DHF documents, including requirements specification, V&V protocols and reports, and risk management files.
• Maintain DHFs and ensure documentation is audit ready.
• Support regulatory submissions by providing required quality and risk management documentation.
• Lead cross-functional discussions to resolve quality issues and improve product design.
• Support complaint investigation, NCRs, CAPAs, and post-market activities to ensure ongoing product quality and compliance.
• Evaluate engineering change orders to ensure continued compliance and product quality.
• Present quality status, risk updates, and design control metrics during project review.
• Communicate quality risks, decisions, and recommendations to leadership and project teams.
• Participate in internal and external audits as required.
• Other responsibilities as assigned by manager.