Supplier Quality Engineer

Job Title: Supplier Quality Engineer (SQE) – FDA Remediation Project

Location: Newark, DE or Marlborough, MA (Onsite)

Employment Type: W2

Duration: 6+ Months Contract

We are hiring an experienced Supplier Quality Engineer to support a high-impact quality and compliance initiative within a regulated medical device environment. This position will play a key role in strengthening supplier quality systems, improving risk management processes, and ensuring compliance with FDA expectations.

• Assess supplier quality performance and identify potential risks across manufacturing and quality systems.
• Drive supplier quality improvements through process evaluations, risk assessments, and corrective action initiatives.
• Partner with suppliers to enhance process controls, inspection methods, and overall product quality.
• Review manufacturing and design risk documentation to ensure alignment with supplier operations.
• Support investigations related to supplier nonconformances, quality events, and compliance concerns.
• Participate in root cause analysis activities and implement effective corrective and preventive actions (CAPAs).
• Assist with qualification and validation efforts for supplier processes and manufacturing changes.
• Work cross-functionally with engineering, quality, and regulatory teams to address quality system gaps.
• Serve as the primary quality liaison for assigned suppliers and support continuous improvement initiatives.

• Bachelor's degree in Engineering or a related technical discipline.
• 5+ years of Supplier Quality Engineering experience within Medical Devices, Life Sciences, Pharmaceuticals, or other regulated manufacturing industries.
• Strong background in supplier quality management, risk assessment, and quality system compliance.
• Experience conducting investigations, CAPA activities, and supplier quality audits.
• Knowledge of FMEA methodologies, quality risk management, and process validation principles.
• Familiarity with FDA-regulated environments and supplier quality controls.
• Excellent communication and stakeholder management skills.

• Exposure to FDA remediation, compliance improvement, or regulatory inspection readiness projects.
• Working knowledge of ISO 13485, FDA Quality System Regulations, and supplier qualification processes.
• Experience supporting supplier process validations and manufacturing quality improvements.