Senior Manufacturing Quality Engineer

Senior Manufacturing Quality Engineer (Medical Device / IVD)

Location:

Marlborough, MA

Seeking a hands‑on Senior Manufacturing Quality Engineer to support manufacturing quality activities for medical devices, with a strong preference for IVD (In Vitro Diagnostics) experience. This role partners closely with Manufacturing, Validation, and Operations teams to ensure compliant, efficient, and high‑quality production processes.

• Provide day‑to‑day quality engineering support for manufacturing operations.
• Support production and process quality activities on the manufacturing floor.
• Lead and support Process Validation and TMV activities.
• Develop and maintain PFMEAs, CAPAs, CPQs, and CTQs.
• Author and update protocols, reports, and quality documentation.
• Collaborate with Manufacturing Engineering, Validation, and Operations teams to drive quality improvements and compliance.

• 5+ years of Quality Engineering experience in medical device manufacturing.
• Strong background in production and process quality.
• Experience supporting electromechanical medical devices.
• Hands‑on expertise with Process Validation, TMV, PFMEA, CAPA, and CPQ/CTQ management.
• Strong technical writing and documentation skills in regulated environments.
• Ability to work independently and support daily manufacturing quality activities.

• IVD (In Vitro Diagnostics) product experience strongly preferred.
• Experience with Agile PLM.

• Hands‑on, execution‑focused quality professional.
• Strong problem‑solving and documentation skills.
• Comfortable working cross‑functionally in a fast‑paced manufacturing environment.