Supplier Quality Remediation Engineer

Title
:
Supplier Quality Remediation Engineer

Duration
: 2+ Years

Locations
:
Marlborough, MA

The Supplier Quality Remediation Engineer will support supplier remediation initiatives following an FDA 483 observation. This role is responsible for leading supplier gap assessments, driving remediation efforts, and ensuring alignment of design and process risk controls with regulatory requirements. The position requires hands‑on collaboration with suppliers and cross‑functional teams to ensure high‑severity risks are properly identified, mitigated, validated, and sustained in compliance with FDA and ISO standards.

• Lead supplier gap assessments and remediation activities following regulatory observations.
• Evaluate supplier process controls using advanced quality engineering methodologies.
• Align design and process risk management controls with regulatory and quality system expectations.
• Perform and review dFMEA and pFMEA with strong emphasis on severity ratings and risk mitigation.
• Conduct process capability analysis (Cp, Cpk) and apply statistical tools to assess process performance.
• Support and review validation activities including IQ, OQ, and PQ.
• Perform and assess Measurement System Analysis (MSA).
• Collaborate directly with suppliers to implement corrective and preventive actions (CAPA).
• Review supplier validation documentation and ensure compliance with FDA QSR and ISO 13485 requirements.
• Communicate remediation status, risk assessments, and action plans to internal stakeholders.

• Bachelor’s degree in Engineering or related technical discipline.
• Experience in medical device or other regulated manufacturing environments.
• Strong expertise in dFMEA and pFMEA, particularly in severity and risk prioritization.
• Experience with process capability analysis (Cp/Cpk).
• Hands‑on experience with IQ/OQ/PQ validation activities.
• Proficiency in Measurement System Analysis (MSA).
• Working knowledge of FDA QSR and ISO 13485.

• Experience supporting supplier remediation following FDA 483 or similar regulatory observations.
• Knowledge of ISO 14971 risk management standards.
• Ability to read and interpret engineering drawings/blueprints.
• Proficiency with statistical analysis tools such as Minitab.