Global Quality Systems Director – Compliance & Transformation

USA-MiniMed Distribution Corp. 1018

Los Angeles (CA)

On-site

USD 180,000 - 240,000

Full time

6 days ago
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Job summary

MiniMed seeks a Quality Systems Director to provide enterprise leadership of the global Quality Management System, strengthening governance, regulatory compliance, and organizational effectiveness.

In this highly visible role, you'll drive QMS strategy, harmonization, training governance, and continual improvement while partnering with senior leaders to identify emerging risks and build scalable quality systems that support patients and the business.

Qualifications

  • Bachelor's degree with 10+ years of quality systems experience and 7+ years experience in people management.
  • Or an advanced degree with 8+ years of quality systems experience and 7+ years experience in people management.

Responsibilities

  • Leads MiniMed Quality Management System framework ensuring effective governance, regulatory compliance, and executive oversight across all MiniMed Quality Management Systems.
  • Establishes and monitors MiniMed's mechanisms to evaluate QMS effectiveness, identify systemic risks, measure performance, and drive continual improvement across global quality organizations.
  • Directs the global quality training governance program, establishing MiniMed competency, qualification, and training effectiveness requirements to ensure consistently implementation across all quality system entities.
  • Provides strategic oversight of Quality Management System change management processes, ensuring significant QMS changes are appropriately assessed, approved, communicated, and implemented across impacted organizations.
  • Leads MiniMed QMS assessments of emerging and revised QMS regulatory requirements, standards, and industry expectations, ensuring timely implementation and alignment of quality system controls across all QMS entities.
  • Drives harmonization, simplification and alignment of quality system requirements, governance models, and best practices across global sites and QMS entities.
  • Leads development of MiniMed quality objectives, quality system metrics and executive reporting mechanisms that provide leadership visibility into QMS performance, compliance status, emerging risks, and organizational effectiveness.
  • Ensures ongoing inspection and audit readiness for the QMS processes in scope and provides executive leadership during regulatory inspections and audits involving those processes.
  • Chairs or leads cross-functional governance forums related to Management Controls, QMS effectiveness, training governance, and quality system maturity to ensure consistent enterprise decision-making.
  • Leads and develops a global Quality Systems organization responsible for MiniMed governance processes, ensuring adequate resources, capability development, succession planning, and operational excellence.

Skills

Quality systems
People management
Regulatory compliance

Education

Bachelor's degree
Advanced degree

Job description

MiniMed seeks a Quality Systems Director to provide enterprise leadership of the global Quality Management System, strengthening governance, regulatory compliance, and organizational effectiveness.

In this highly visible role, you'll drive QMS strategy, harmonization, training governance, and continual improvement while partnering with senior leaders to identify emerging risks and build scalable quality systems that support patients and the business.

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