Supplier Quality Manager

JBL Resources; Caledonia (MI); In loco; USD 110.000 - 160.000; Tempo pieno

Descrizione del lavoro

JBL Resources is seeking a Supplier Quality Manager in the Greater Grand Rapids area to lead supplier quality initiatives for a medical device manufacturer. The role focuses on KPIs, supplier performance, SCAR management, audits, and cross-functional collaboration to ensure patient safety and regulatory compliance.

The ideal candidate will have deep regulatory knowledge (FDA QMSR, ISO 13485, ISO 9001), 7–10 years in quality with 3–5 years in supplier quality, and certifications such as CQE/CQA

Competenze

• Bachelor’s degree required 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 QMSR, ISO 13485, and ISO 9001 standards.
• Certifications such as ASQ CQE, CQA, Six Sigma, or Lean.
• Strong leadership and cross-functional influence.
• Willingness to travel up to 25%, domestically and internationally.

Mansioni

• Establish and maintain supplier quality KPIs and dashboards for the enterprise.
• Escalate critical supplier quality issues at international sites.
• Conduct supplier performance reviews and drive corrective actions and improvement plans.
• Manage SCAR process with thorough root cause analyses and timely closures.
• Develop supplier scorecards and risk-based audit programs.
• Lead audits against ISO 13485 and FDA 21 CFR Part 820 and related standards.
• Assess supplier quality management systems for adequacy and continuous improvement.
• Support regulatory inspections with complete supplier documentation.
• Ensure inspection procedures and acceptance criteria align with standards.
• Collaborate with Supply Chain to drive supplier restitution and issue resolution.

Conoscenze

Leadership

Communication

Regulatory awareness

Formazione

Bachelor’s degree in Engineering or Life Sciences or Quality Management

ASQ CQE / CQA / Six Sigma / Lean Certification

Descrizione del lavoro

Supplier Quality Manager

Location: Greater Grand Rapids Area

About Our Client:

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.

JBL is an Equal Opportunity Employer and E-Verify Company