CAPA Engineer; Medical Devices

Title

CAPA Engineer (Medical Devices)

Greater Andover Area, MA (Hybrid 3 days onsite)

Contract

Accepting Candidates

This role supports the organization’s quality management systems by driving compliance, improving processes, and enabling strong investigation and audit readiness. You will partner cross-functionally to support CAPA execution, complaint handling, risk activities, and supplier quality processes.

• Support and maintain quality management system elements including CAPA, complaints, and audit activities.
• Provide input to investigations and root-cause analyses across quality issues.
• Assist in supplier controls, risk review, and management review processes.
• Generate reporting, metrics, and documentation to support compliance and quality performance.
• Collaborate with functional partners to drive continuous improvement within QMS programs.

• Bachelor’s degree in Engineering, Life Sciences, or related discipline.
• 3–6 years of Quality Systems or product quality experience in the medical device industry.
• Working knowledge of FDA and ISO quality regulations (21 CFR Part 820, ISO 13485, EU MDR).
• Experience supporting CAPA investigations, complaint management, audits, and documentation.
• Strong problem-solving skills and familiarity with quality tools such as RCA, FMEA, or DOE.

• Estimated hourly range: $60–$70/hr (W‑2).
• Final rate within this range will be based on skills, experience, and interview results.