Senior Quality Engineer

We are seeking a Senior Design Quality Assurance Engineer to provide hands-on sustaining quality support for medical devices in a regulated environment. This role will focus on product quality, risk management, nonconformance investigations, CAPAs, and Design History File (DHF) assessment and remediation. The consultant will work closely with cross-functional partners within a smaller, collaborative team environment. The ideal candidate is proactive, positive, and driven, with strong communication skills and the ability to work independently while building effective working relationships. Key Responsibilities Own and maintain product risk management activities, including risk assessments and associated documentation. Lead and support nonconformance events, including NCEP/NCMR investigations, documentation, and resolution. Manage and support CAPA activities, including root-cause investigations, corrective actions, and effectiveness checks. Conduct DHF assessments and support remediation efforts to address documentation gaps and ensure design control compliance. Provide ongoing Design Quality Assurance support for sustaining products throughout the product lifecycle. Assess product and design changes to ensure appropriate risk evaluation, documentation, and compliance with applicable quality requirements. Collaborate with cross-functional stakeholders to investigate quality issues, resolve problems, and maintain product compliance. Develop, review, and maintain quality documentation in accordance with applicable procedures, regulations, and industry standards. Communicate quality risks, project updates, and recommended actions clearly to internal stakeholders. Required Qualifications 4-10 years of experience in medical device quality engineering or a related regulated industry. Strong experience in Design Quality Assurance, preferably supporting sustaining products. Demonstrated ownership of product risk management activities and documentation. Hands-on experience with nonconformance management (NCEP/NCMR) and CAPA processes. Strong written and verbal communication skills. Ability to work independently, take initiative, and collaborate effectively across functions. Strong technical documentation, problem-solving, and organizational skills. Preferred Qualifications Experience conducting DHF assessments, remediation, or design control gap assessments. Experience supporting sustaining engineering and ongoing product quality activities. Familiarity with ISO 13485, ISO 14971, FDA Quality System Regulation (21 CFR Part 820/QMSR), and applicable design control requirements. Experience leading root‑cause investigations and driving quality improvements. Ability to build relationships and communicate effectively within a small, cross-functional team. #J-18808-Ljbffr