Supplier Quality Engineer

Location:
Minnesota or Carlsbad, CA (100% Onsite)

Employment Type:
W2 Contract

Duration:
Long term

We're seeking an experienced Supplier Quality Engineer to support a leading medical device client. This role is ideal for a quality professional with a strong background in supplier quality, manufacturing quality, and quality systems within the medical device industry. The selected candidate will work closely with suppliers, manufacturing teams, operations, and cross‑functional stakeholders to ensure compliance with regulatory standards while driving continuous quality improvements.

• Manage supplier quality activities throughout the product lifecycle.
• Perform supplier qualification, audits, assessments, and ongoing supplier performance monitoring.
• Support Operations Quality and Manufacturing Quality initiatives to improve product quality and process capability.
• Conduct supplier audits in compliance with ISO 13485 and internal Quality Management System (QMS) requirements.
• Lead material qualification activities including First Article Inspection (FAI), IQ/OQ/PQ, PPAP, process validation, and manufacturing readiness.
• Investigate quality issues, perform root cause analysis, and drive CAPA implementation to prevent recurrence.
• Participate in Material Review Board (MRB) activities, material disposition, and nonconformance investigations.
• Partner with Engineering, Manufacturing, Regulatory Affairs, and Supply Chain teams to resolve supplier‑related quality issues.
• Drive continuous improvement initiatives using Lean, Six Sigma, DMAIC, and statistical problem‑solving methodologies.
• Ensure supplier compliance with FDA regulations, ISO 13485 requirements, and internal quality procedures.
• Review quality metrics and supplier performance data to identify trends and improvement opportunities.
• Support product transfers, supplier change management, and manufacturing process improvements.

• Bachelor's degree in a STEM field
• 6+ years of medical device industry experience
• Strong experience in Supplier Quality, Operations Quality, and Manufacturing Quality Engineering
• Supplier auditing, QMS, and manufacturing process expertise
• Experience with First Article Inspection (FAI), IQ/OQ/PQ, PPAP, and material qualification
• Hands‑on experience with CAPA, DMAIC/Six Sigma, MRB, and material disposition
• Excellent communication, stakeholder management, and cross‑functional collaboration skills

• Strong understanding of manufacturing processes within the medical device industry.
• Excellent analytical and problem‑solving skills.
• Ability to interpret engineering drawings, specifications, and quality documentation.
• Experience working with cross‑functional teams in fast‑paced manufacturing environments.
• Strong organizational skills with the ability to manage multiple priorities.