Supplier Quality Engineer

Our partner is looking for a Supplier Quality Engineer to join our Operations team to take the lead in managing our critical supplier relationships and ensuring the quality and compliance of all our products. In this pivotal role, you will serve as the primary quality interface between the company's and our supplier network, leading qualification processes, conducting risk assessments and audits, investigating quality issues, and driving continuous improvement initiatives—all while ensuring strict adherence to FDA regulations, ISO 13485 and international standards. The ideal candidate combines technical expertise with strong relationship management skills to maintain our high standards of product quality and safety.

Responsibilities to include:

• Supplier Qualification & Management:
  • Lead the qualification process for new suppliers, conducting risk assessments, capability evaluations, and quality system audits.
  • Develop and maintain the Approved Supplier List (ASL) based on performance, compliance, and risk analysis.
  • Collaborate with procurement and R&D to ensure suppliers meet technical and regulatory requirements.
  • Establish and monitor supplier Key Performance Indicators (KPIs), such as defect rates and compliance metrics.
• Supplier Audits & Compliance:
  • Plan, execute, and document supplier audits in compliance with FDA, ISO 13485, and internal quality requirements.
  • Ensure suppliers implement corrective and preventive actions (CAPAs) for any non-conformances identified during audits.
  • Maintain supplier audit schedules and track follow-up activities to ensure timely resolution of findings.
• Supplier Issue Management & Continuous Improvement:
  • Investigate supplier-related quality issues, including non-conforming materials, component failures, and deviations.
  • Work closely with suppliers to implement process improvements, reduce defects, and enhance product reliability.
• Regulatory Compliance & Documentation:
  • Ensure supplier documentation, such as Certificates of Compliance (CoC) and process validations, meet regulatory requirements.
  • Maintain supplier-related quality records in compliance with ISO 13485, and other relevant standards.
  • Support regulatory and customer audits by providing supplier-related quality documentation and evidence of compliance.
• Cross-Functional Collaboration;

• Partner with Operations, Engineering, and Procurement teams to resolve supplier-related manufacturing issues.
• Participate in Design Review meetings to provide input on supplier capabilities and constraints.
• Support complaint investigations related to supplier components and materials.

What You Will Need

• Bachelor's degree in Engineering, Quality, or related technical field.
• 4 years of experience in supplier quality within the medical device industry.
• Thorough knowledge of FDA regulations, ISO 13485, and medical device quality systems.
• Certified quality professional (CQE, CQA, or equivalent) preferred.
• Experience with risk management methodologies (FMEA, FTA) and statistical process control.
• A keen eye for detail and a results-driven approach
• Strong auditing skills with demonstrated ability to identify and resolve quality issues.
• Excellent verbal communication skills with ability to speak effectively with clients, vendors, management staff and employees of organization
• Working knowledge of Microsoft Excel, Word, Access, Visio, and documentation control software (preferably Aras PLM), material management software, and statistical application software
• Willingness to travel (approximately 20-30%) for supplier audits and assessments.

Who You Will Work With

Our partner is an organization that values collaboration and community. As the Supplier Quality Engineer, you will work closely with Operations, Engineering, and Procurement teams.