Senior Global Supplier Quality Leader – Medical Devices

JBL Resources; Grand Rapids (MI); Vor Ort; USD 120.000 - 170.000; Vollzeit

Zusammenfassung

JBL Resources in Grand Rapids, MI, is seeking a seasoned Supplier Quality Manager to lead quality performance across international supplier base in a medical device manufacturing environment. The role emphasizes strong governance of KPIs, audits, SCARs, and continuous improvement.

You will develop KPI dashboards, conduct audits against FDA and ISO standards, and drive corrective actions while traveling up to 25%.

Qualifikationen

• Bachelor’s degree in Engineering, Life Sciences, Quality Management, or related field.
• 7–10 years in quality within regulated manufacturing environments, 3–5 years in supplier quality.
• Deep knowledge of FDA QMSR, ISO 13485, and ISO 9001 standards.
• Experience conducting supplier audits and managing SCARs.
• Experience in surgical or single-use medical devices.
• Willingness to travel up to 25% domestically and internationally.
• No C2C candidates.

Aufgaben

• Establish supplier quality KPIs and report performance to QA/RA, Supply Chain, and leadership.
• Escalate critical supplier quality issues at international manufacturing, procurement, and distribution sites.
• Conduct supplier performance reviews and drive corrective actions and improvements.
• Manage the SCAR process, ensuring thorough root cause analyses and timely closure.
• Develop supplier scorecards and dashboards for enterprise-wide visibility.
• Plan and execute a risk-based supplier audit program, on-site and remote.
• Lead audits against ISO 13485 and FDA 21 CFR 820, document findings, and drive corrective actions.
• Assess supplier quality management systems for adequacy and continuous improvement.
• Support regulatory inspections with complete supplier documentation.
• Implement non-conforming product identification and remediation with supply chain accountability.
• Ensure inspection procedures, sampling plans, and acceptance criteria align with standards.

Kenntnisse

Leadership

Cross-functional collaboration

Analytical thinking

Excellent communication

Ausbildung

Bachelor's degree in Engineering or Life Sciences

Jobbeschreibung

JBL Resources in Grand Rapids, MI, is seeking a seasoned Supplier Quality Manager to lead quality performance across international supplier base in a medical device manufacturing environment. The role emphasizes strong governance of KPIs, audits, SCARs, and continuous improvement.

You will develop KPI dashboards, conduct audits against FDA and ISO standards, and drive corrective actions while traveling up to 25%.