Global Supplier Quality Leader

Aspen Surgical; Caledonia (MI); On-site; USD 120,000 - 180,000; Full time

Job summary

Aspen Surgical is seeking a Supplier Quality Manager to lead global supplier quality processes in a regulated medical-device environment. You will own the end-to-end program, from qualification and onboarding to performance management, auditing and continuous improvement, while leading a growing team of SQEs.

The role includes finished goods supplier quality accountability at the Caledonia, MI distribution center.

Qualifications

• Demonstrated experience conducting supplier audits and driving performance improvement.
• Experience managing supplier qualification programs, ASL, audits and supplier evaluation systems.
• Leadership experience with site resources and cross-functional teams.

Responsibilities

• Own global supplier qualification process aligned with FDA QMSR and ISO 13485.
• Lead onboarding of new suppliers ensuring on-time readiness.
• Maintain Approved Supplier List (ASL) and audit-ready documentation.
• Manage SCAR process with robust root-cause analyses and timely closures.
• Develop supplier scorecards and dashboards for enterprise-wide visibility.
• Plan and execute risk-based supplier audits across domestic and international sites.
• Lead audits against ISO 13485 and FDA 21 CFR Part 820 and drive corrective actions.
• Assess supplier QA systems for adequacy and continuous improvement.
• Support M&A due diligence and integration from a supplier quality perspective.
• Drive continuous improvement of Aspen’s supplier quality program.

Skills

QMSR FDA

ISO 13485

Supplier audits

SCAR management

CAPA

FMEA

Root cause analysis

Control plans

Statistical sampling

Leadership

Cross-functional alignment

Data analysis

Prioritization

Education

Bachelor’s degree in Engineering, Life Sciences, Quality Management, or related field

Tools

ERP systems

Job description

Aspen Surgical is seeking a Supplier Quality Manager to lead global supplier quality processes in a regulated medical-device environment. You will own the end-to-end program, from qualification and onboarding to performance management, auditing and continuous improvement, while leading a growing team of SQEs.

The role includes finished goods supplier quality accountability at the Caledonia, MI distribution center.