Sr Design 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.