Manufacturing quality engineering

Supplier Quality Engineer (SQE)

Job Type: Contract-to-Hire

We are seeking a Supplier Quality Engineer (SQE) to manage supplier quality performance, ensure regulatory compliance, and drive continuous improvement initiatives within a regulated manufacturing environment. The ideal candidate will work closely with suppliers and cross-functional teams to resolve quality issues, reduce risk, support audits, and improve supplier processes and product quality.

Manage supplier quality performance through audits, metrics, risk assessments, and supplier development activities.

Lead supplier audits and ensure compliance with FDA, ISO 13485, ISO 14971, GMP, and quality system requirements.

Drive supplier investigations, CAPA, SCAR, root cause analysis, and corrective action effectiveness.

Partner with Procurement, Manufacturing, Operations, Engineering, Quality, and R&D teams to resolve supplier-related issues.

Lead continuous improvement projects using Lean Six Sigma tools such as DMAIC, FMEA, SPC, MSA, DOE, and Kaizen.

Support regulatory inspections, supplier compliance reviews, and risk management initiatives.

Bachelor's Degree in Engineering or a related technical discipline.

• 5+ years of Supplier Quality, Quality Engineering, or Supplier Development experience.
• Experience conducting supplier audits and managing supplier quality systems.
• Strong analytical, problem-solving, and project management skills.

Medical Device, Pharmaceutical, Biotechnology, or other highly regulated manufacturing experience. Lean Six Sigma Green Belt/Black Belt or CQE certification.

Bilingual English/Spanish communication skills preferred