Quality Systems Director

USA-MiniMed Distribution Corp. 1018

Los Angeles (CA)

On-site

USD 180,000 - 240,000

Full time

3 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

We anticipate the application window for this opening will close on - 1 Nov 2026

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

About the Role

At MiniMed, quality is at the heart of our commitment to improving the lives of people living with diabetes. We're looking for a Quality Systems Director to provide enterprise leadership and strategic oversight of our global Quality Management System, strengthening governance, regulatory compliance, and organizational effectiveness across MiniMed. In this highly visible leadership role, you'll drive QMS strategy, harmonization, training governance, and continuous improvement while partnering with senior leaders across the organization to identify emerging risks, and build scalable quality systems that support our business and the patients we serve.

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.
Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

  • Bachelors Degree with 10+ years of quality systems experience and 7+ years experience in people management
  • OR
  • Advanced Degree with 8+ years of quality systems experience and 7+ years experience in people management
Nice To Have
  • Previous experience leading Quality Systems Teams within medical device industry
  • Experience with leading and supporting FDA auditing
  • Previous PMS experience
  • Experience leading large organizations in strategy and execution of quality systems
  • Previous experience developing global quality systems strategy
Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offe

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