Our client is a well-established medical device manufacturer located in the Greater Grand Rapids area, specializing in the development and production of high-quality surgical products used by healthcare professionals worldwide. The organization is known for its strong commitment to patient safety, innovation, and operational excellence, and offers a collaborative, quality-driven environment focused on continuous improvement.
Key Responsibilities:
- Establishing and maintaining supplier quality KPIs, including incoming product defect rates, supplier corrective action cycle time, on-time delivery, and overall supplier quality scores, and reporting performance to QA/RA, Supply Chain, and leadership.
- Escalating critical supplier quality issues arising at international manufacturing, procurement, and distribution sites.
- Conducting regular supplier performance reviews, identifying underperforming suppliers, and driving corrective actions and improvement plans.
- Managing the Supplier Corrective Action Request (SCAR) process, ensuring root cause analyses are thorough, corrective actions are effective, and closure is timely.
- Developing and maintaining supplier scorecards and performance dashboards that provide clear, data-driven visibility into supplier quality across the enterprise.
- Planning and executing a risk-based supplier audit program, conducting on-site and remote quality system audits across domestic and international supplier base.
- Leading audit activities against ISO 13485, FDA 21 CFR Part 820, and applicable regulatory standards, documenting findings, and driving timely corrective actions.
- Assessing supplier quality management systems for adequacy, compliance, and continuous improvement orientation across the organization.
- Supporting internal and external regulatory inspections by ensuring supplier quality documentation and records are complete, accurate, and readily available.
- Implementing non-conforming product identification and documentation processes, ensuring supplier issues and trends are acted upon, escalated, and managed through resolution, while holding suppliers accountable for restitution working with Supply Chain.
- Ensuring inspection procedures, sampling plans, and acceptance criteria align with applicable standards and risk-based principles.
- Establishing systems and documentation practices to specify material requirements through specifications and drawings.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, Quality Management, or related field.
- 7–10 years of quality experience in a regulated manufacturing environment, with at least 3–5 years in supplier quality.
- Deep knowledge of FDA’s QMSR, ISO 13485, and ISO 9001 standards.
- Proven experience conducting supplier audits, managing SCARs, and improving supplier performance.
- Experience in surgical or single-use medical devices.
- Certifications such as ASQ CQE, CQA, Six Sigma, or Lean.
- Strong leadership skills, both in managing teams and influencing cross-functional partners.
- Excellent communication skills, with capacity to present complex data simply and clearly.
- Willingness to travel up to 25%, domestically and internationally.
- NO C2C CANDIDATES
**JBL is an Equal Opportunity Employer and E-Verify Company