Supply Qulaity Engineer

Role: Supplier Quality Remediation Engineer

Location (Onsite – choose one):

• Newark, DE
• Marlborough, MA
• New Hampshire

We are hiring a Supplier Quality Remediation Engineer to support supplier remediation efforts following an FDA 483 observation. This role is highly hands‑on and focused on driving corrective actions with suppliers, performing gap assessments, and ensuring alignment with FDA and ISO regulatory expectations.

You will work directly with suppliers and internal stakeholders to identify high‑severity risks, implement sustainable controls, and support validation and risk management activities within a regulated medical device environment.

• Lead supplier gap assessments and remediation activities in response to FDA 483 observations
• Evaluate supplier process and design controls using quality engineering tools
• Drive dFMEA and pFMEA activities with strong focus on severity and risk mitigation
• Support and review process validation activities (IQ/OQ/PQ)
• Perform process capability analysis (CpK) and Measurement System Analysis (MSA)
• Collaborate directly with suppliers to execute CAPAs and corrective actions
• Review supplier documentation, validation reports, and risk management files
• Communicate remediation status, risks, and action plans to internal teams
• Ensure compliance with FDA QSR, ISO 13485, and ISO 14971

• Bachelor’s degree in Engineering or related discipline
• 5+ years of experience in medical device or regulated manufacturing environments
• Strong hands‑on experience with:
• dFMEA / pFMEA
• IQ / OQ / PQ
• Process Capability (CpK)
• Measurement System Analysis (MSA)
• Experience supporting supplier quality remediation
• Working knowledge of FDA QSR, ISO 13485, ISO 14971
• Ability to work onsite and engage directly with suppliers

• Blueprint reading and GD&T knowledge
• Proficiency with Minitab or similar statistical tools
• Strong communication and stakeholder management skills