Global Supplier Quality Leader

Aspen Surgical; Michigan; On-site; USD 110,000 - 160,000; Full time

Job summary

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

This role partners with QA/RA, Supply Chain and engineering to drive supplier qualification, audits, CAPA, and risk-based supplier programs,

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field required.
• Minimum of 7-10 years of quality experience in a medical device or regulated manufacturing environment, with at least 3-5 years in a supplier quality role.
• Experience managing supplier qualification programs, Approved Supplier Lists, audit programs and supplier evaluation systems.
• Strong working knowledge of FDA’s QMSR, ISO 13485, and ISO 9001.
• Leadership experience includes both direct employee leadership and influential organizational leadership for site resources.

Responsibilities

• Own and drive alignment of the global supplier qualification process, including quality system evaluations and supplier approvals.
• Lead supplier audits, SCARs, and corrective action planning across international sites.
• Develop and maintain supplier scorecards and KPI reporting for leadership.
• Plan and execute risk-based supplier audit programs and on-site/remote assessments.
• Monitor regulatory changes and ensure ongoing compliance of supplier quality programs.

Skills

Quality leadership

Supplier audits

SCAR process

Quality metrics

Regulatory knowledge

Cross-functional collaboration

Travel readiness

Education

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

Tools

ERP systems

Quality management software

Job description

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

This role partners with QA/RA, Supply Chain and engineering to drive supplier qualification, audits, CAPA, and risk-based supplier programs,