Supplier Quality Engineer

Job Title:

Supplier Quality Remediation Engineer

Marlborough, MA (Onsite)

The Supplier Quality Remediation Engineer will support supplier remediation activities following FDA regulatory observations. This role focuses on leading supplier gap assessments, driving corrective actions, and ensuring design and process risk controls meet FDA and ISO requirements in regulated manufacturing environments.

• 4+ years of experience in Medical Device or regulated manufacturing environments
• Hands‑on supplier quality and remediation experience
• Support of FDA 483 observations and remediation activities
• Strong expertise in dFMEA and pFMEA (severity‑focused risk assessment)
• Process validation experience (IQ / OQ / PQ)
• Process capability analysis (Cp / Cpk)
• Measurement System Analysis (MSA / Gage R&R)
• Working knowledge of FDA QSR, ISO 13485, and ISO 14971
• Experience using statistical tools (e.g., Minitab)

• Lead supplier gap assessments and remediation activities
• Evaluate supplier process controls and identify high‑severity risks
• Drive corrective actions aligned with FDA and ISO expectations
• Review and support supplier validation and qualification activities
• Collaborate directly with suppliers and internal stakeholders to sustain compliance