Supplier Quality Engineer

Work Authorization:

Must be authorized to work in the U.S. (no sponsorship available)

Up to $54/hr

Potential extension and possible contract‑to‑hire for the right candidate

We are seeking a Supplier Quality Engineer III to support a high‑visibility remediation project focused on strengthening the linkage between design risks, design outputs, and manufacturing processes performed by external suppliers. This role is ideal for an engineer who thrives in a fast‑paced, cross‑functional environment and is comfortable working directly with both internal teams and 10–20 contract manufacturers.

You’ll collaborate closely with design engineering, supplier engineering, and quality teams to evaluate supplier validation packages, identify gaps, and drive remediation activities that ensure compliance with newly defined criteria. Strong communication skills are essential—this role requires someone who is proactive, confident, and comfortable picking up the phone to keep work moving.

• Review, remediate, and approve supplier process risk documentation (PFMEA) to align with updated criteria.
• Evaluate supplier process and inspection validations to ensure they meet statistical and documentation requirements.
• Lead change management activities to address gaps in supplier risk documentation and validation packages.
• Partner with contract manufacturers and internal teams to complete all remediation activities and achieve approval of updated documentation.

• Work closely with design engineering, sustaining supplier engineering, and quality engineering to identify critical design outputs and ensure proper linkage to supplier processes.
• Communicate effectively with internal stakeholders and external suppliers to drive progress and resolve issues.

• Ensure all work aligns with quality system requirements and supports a strong commitment to product quality and patient safety.
• Maintain thorough documentation of remediation activities and approvals.

• 1–2 years of experience in a manufacturing environment
• Experience with:
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Test Method Validation (TMV)
• Ability to travel up to 15% (primarily domestic, occasional international)

• Experience working with suppliers or within supply chain environments
• Background in the medical device industry
• Strong communication and project management skills
• Action‑oriented, self‑driven, and motivated to learn
• Solid understanding of statistical methods, Six Sigma tools, and structured problem‑solving methodologies

Build quality into all aspects of work by maintaining full compliance with all applicable quality system requirements.