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MiniMed

Develops automated insulin delivery systems

Quality Systems Director

Regulatory & Quality (Life Sciences)Updated on Nov 12
Full-timeLos Angeles, CA, USAIn-person

About the Job

Requirements

  • A bachelor's degree and at least 10 years of quality systems experience, with at least 7 years of people-management experience, or an advanced degree and at least 8 years of quality systems experience, with at least 7 years of people-management experience.

Responsibilities

  • Lead MiniMed's Quality Management System framework to ensure effective governance, regulatory compliance, and executive oversight across all MiniMed Quality Management Systems.
  • Establish and monitor mechanisms to evaluate Quality Management System effectiveness, identify systemic risks, measure performance, and drive continual improvement across global quality organizations.
  • Direct the global quality training governance program by establishing competency, qualification, and training-effectiveness requirements for consistent implementation across quality system entities.
  • Provide strategic oversight of Quality Management System change management processes, ensuring significant changes are assessed, approved, communicated, and implemented across impacted organizations.
  • Lead assessments of emerging and revised Quality Management System regulatory requirements, standards, and industry expectations, ensuring timely implementation and alignment of quality system controls across all entities.
  • Drive harmonization, simplification, and alignment of quality system requirements, governance models, and best practices across global sites and quality system entities.
  • Lead development of quality objectives, quality system metrics, and executive reporting mechanisms to provide leadership visibility into system performance, compliance status, emerging risks, and organizational effectiveness.
  • Ensure ongoing inspection and audit readiness for in-scope Quality Management System processes and provide executive leadership during related regulatory inspections and audits.
  • Chair or lead cross-functional governance forums concerning Management Controls, Quality Management System effectiveness, training governance, and quality system maturity.
  • Lead and develop a global Quality Systems organization responsible for governance processes, ensuring adequate resources, capability development, succession planning, and operational excellence.

Desired Qualifications

  • Previous experience leading Quality Systems teams within the medical device industry.
  • Experience leading and supporting FDA auditing.
  • Previous post-market surveillance experience.
  • Experience leading large organizations in quality systems strategy and execution.
  • Previous experience developing global quality systems strategy.

About the Company

MiniMed

Develops automated insulin delivery systems

MiniMed develops insulin delivery and automated insulin delivery systems, plus related sensors, pens, and software. Its products couple glucose sensors with pumps or smart pens to automatically adjust insulin or simplify dosing. It differentiates itself with an integrated ecosystem of devices and software and a large share of recurring revenue from sensors, consumables, software and services across more than 80 countries. Its goal is to be a leading global provider of insulin delivery and glucose monitoring solutions that help people with diabetes achieve better glycemic control.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Los Angeles, CA
Founded
1983

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