We're Hiring: Senior Supplier Quality Engineer
Location: Minneapolis, MN 55432 (Onsite)
Job Description:
We are looking for an experienced Senior Supplier Quality Engineer to support supplier quality and manufacturing quality activities within the medical device industry. The ideal candidate will have hands‑on experience with supplier quality management, supplier development, APQP, PPAP, and quality system processes.
Key Responsibilities:
- Manage supplier quality activities, ensuring purchased materials, components, and manufacturing processes meet engineering specifications and quality requirements.
- Lead supplier qualification, evaluation, approval, and ongoing performance monitoring activities.
- Review and evaluate APQP documentation, PPAP submissions, PFMEA, Control Plans, process flow diagrams, and First Article Inspection (FAI) reports.
- Work closely with suppliers to identify quality issues, investigate nonconformances, and implement effective corrective and preventive actions (CAPA).
- Lead supplier corrective action requests (SCARs), root cause investigations, and continuous improvement initiatives.
- Conduct supplier audits and assessments to evaluate manufacturing capabilities, process controls, and compliance with quality requirements.
- Support new product introductions (NPI) by assessing supplier readiness, manufacturing processes, and quality documentation.
- Monitor supplier performance metrics, identify improvement opportunities, and drive initiatives to improve product quality and supplier reliability.
- Collaborate with cross-functional teams, including Engineering, Manufacturing, Operations, and Quality, to resolve supplier-related issues.
- Ensure supplier processes and documentation comply with applicable medical device quality standards and regulatory requirements.
Required Qualifications:
- Bachelor's degree in Engineering or a related technical discipline.
- Minimum 5+ years of relevant experience, or 3+ years with an advanced degree.
- Strong experience in Supplier Quality Engineering within the medical device industry.
- Hands‑on experience with PPAP and APQP.
- Knowledge of PFMEA, Control Plans, FAI, supplier audits, CAPA, NCR, and SCAR.
- Experience with root cause analysis and corrective action methodologies.
- Strong understanding of supplier qualification, supplier development, and quality management systems.
- Excellent communication and cross‑functional collaboration skills.
Preferred Qualifications:
- Medical device manufacturing experience, particularly with regulated products.
- Experience leading supplier quality improvement initiatives and resolving complex supplier issues.
- Knowledge of ISO 13485 and FDA quality system requirements.