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Job title
Senior Quality Engineer - Medical Devices Location:
Massachusetts Employment Type:
Full-time Overview
I’m working with a leading medical device manufacturer who is looking to bring on board a Senior Quality Engineer to strengthen their quality and compliance function. This is a fantastic opportunity for an experienced professional with strong knowledge of medical device regulations and quality systems to step into a senior role with real influence. Responsibilities
Lead quality engineering activities across the product lifecycle, from concept and design to commercial release and post-market. Support compliance with ISO 13485, FDA QSRs, MDSAP, and MDR. Drive risk management processes in line with ISO 14971. Oversee design control activities, verification/validation, and documentation reviews. Lead and support internal and external audits, ensuring audit readiness. Investigate nonconformances, lead root cause analysis, and manage CAPA through to closure. Collaborate with suppliers and internal teams to ensure quality standards are met. Provide guidance, coaching, and technical leadership to junior engineers. Identify and implement continuous improvement opportunities in quality systems and processes. What We’re Looking For
Degree in Engineering, Life Sciences, or a related discipline. 5–7+ years’ experience in quality engineering within the medical device industry. Strong understanding of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and EU MDR. Proven experience with design controls, risk management, validation, and CAPA. Comfortable leading audits with regulatory bodies and notified bodies. Excellent communicator with strong problem-solving skills. CQE or similar certification is a plus. Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Medical Equipment Manufacturing Note: This listing excludes boilerplate postings and reduces extraneous sections to focus on role-specific information.
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Senior Quality Engineer - Medical Devices Location:
Massachusetts Employment Type:
Full-time Overview
I’m working with a leading medical device manufacturer who is looking to bring on board a Senior Quality Engineer to strengthen their quality and compliance function. This is a fantastic opportunity for an experienced professional with strong knowledge of medical device regulations and quality systems to step into a senior role with real influence. Responsibilities
Lead quality engineering activities across the product lifecycle, from concept and design to commercial release and post-market. Support compliance with ISO 13485, FDA QSRs, MDSAP, and MDR. Drive risk management processes in line with ISO 14971. Oversee design control activities, verification/validation, and documentation reviews. Lead and support internal and external audits, ensuring audit readiness. Investigate nonconformances, lead root cause analysis, and manage CAPA through to closure. Collaborate with suppliers and internal teams to ensure quality standards are met. Provide guidance, coaching, and technical leadership to junior engineers. Identify and implement continuous improvement opportunities in quality systems and processes. What We’re Looking For
Degree in Engineering, Life Sciences, or a related discipline. 5–7+ years’ experience in quality engineering within the medical device industry. Strong understanding of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and EU MDR. Proven experience with design controls, risk management, validation, and CAPA. Comfortable leading audits with regulatory bodies and notified bodies. Excellent communicator with strong problem-solving skills. CQE or similar certification is a plus. Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Medical Equipment Manufacturing Note: This listing excludes boilerplate postings and reduces extraneous sections to focus on role-specific information.
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