Supplier Quality Engineer - Medical Device

Job Description:

Supplier Quality Remediation Engineer

Duration: 2+ years

Work Location:
Onsite

The Supplier Quality Remediation Engineer will support supplier remediation activities following an FDA 483 observation. This role is responsible for leading supplier gap assessments and remediation efforts, with a strong emphasis on aligning design and process risk controls with regulatory and quality system requirements.

The engineer will evaluate supplier process controls using advanced quality engineering methodologies to ensure high‑severity risks are properly identified, mitigated, and sustained in compliance with FDA and ISO standards.

• Lead supplier gap assessments and remediation activities related to FDA 483 observations
• Partner directly with suppliers to drive corrective and preventive actions
• Evaluate and align design and process risk controls to regulatory expectations
• Review and support supplier validation activities, including IQ/OQ/PQ
• Perform and assess process capability studies (cPk) and Measurement System Analysis (MSA)
• Ensure remediation actions are effectively implemented and sustained
• Communicate findings, risks, and action plans to internal cross‑functional stakeholders

• Bachelor’s degree in Engineering or related field
• Minimum of 5 years of experience in medical device or other regulated manufacturing environments
• Strong hands‑on experience with:
• dFMEA and pFMEA (with focus on severity ratings)
• Process capability analysis (cPk)
• IQ/OQ/PQ validation
• Measurement System Analysis (MSA)

• Experience supporting supplier remediation efforts following regulatory observations (FDA 483 preferred)
• Working knowledge of FDA QSR, ISO 13485, and ISO 14971
• Ability to read and interpret engineering blueprints
• Proficiency with statistical tools such as Minitab