Quality Systems Director - Diabetes

Director, Quality Systems | Diabetes

Are you a decisive Quality professional who can build a ‘Culture of Quality’ through tangible strategies? Are you looking for meaningful work with a higher purpose that can impact people’s lives each day? Up for a challenge?

Medtronic Diabetes is seeking individuals with proven expertise in creating and managing Quality Management Systems who have championed a ‘Culture of Quality’ across a global organization. Last year, Medtronic improved the lives of more than 10 million people around the world. Every 3 seconds a life is improved by a Medtronic product or therapy —all part of our mission to alleviate pain, restore health and extend life's. We believe people living with diabetes deserve the highest quality products and services to help them enjoy greater freedom and better health.

We are looking for a Director to lead our Quality Management System (QMS) team at our Northridge, CA headquarters. We expect you will bring your expertise, personal drive and collaborative mindset to our team and share in the growth of our exciting and innovative portfolio of products.

What we expect from you:

• Lead the strategic development and maintenance of quality programs, systems, processes and procedures that are streamlined for impact and adoption.
• Demonstrate teamwork that seizes great ideas to drive action and results.
• Build a team of trusted Quality professionals who influence through expertise and collaboration across our global stakeholders to demonstrate the transformative value of our Quality systems.
• Provide your leadership, expertise and guidance in interpreting policies that confidently navigate us through complex regulatory and compliance pathways.
• Help the organization maintain 100% audit readiness and inspection preparation while fostering strong relationships with the FDA and other audit/inspection agencies.

• Ensure our global quality assurance programs and policies are maintained and modified regularly with clear, uniform standards (including documentation related to CAPA
• Build trusted foundations across the organization. The person in this role is expected to work onsite in Northridge at least 3 days per week and we may provide relocation assistance as appropriate.

Minimum Qualifications

• Bachelor’s Degree Required and 10 years of Quality engineering experience including 7 years of people management experience

• Or an advanced degree with a minimum of 8 years of Quality engineering experience with 7 years of people management experience.

Preferred Qualifications

• Experience with European Union's Medical Device Regulations (EUMDR) knowledge and at least 2 years of experience preparing EUMDR technical documentation
• Direct experience with FDA Warning Letter Remediation and/or FDA 483 Observations

• Lean or Six Sigma Certification Preferred
• Master’s Degree Preferred
• Demonstrated ability to simply and clearly convey and communicate complex concepts to a variety of stakeholders at all levels in the organization
• Bachelor’s Degree in Engineering or related technical field preferred

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

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. (ADA-United States of America)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.

MIP Eligible: This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.

LTI Eligible: This position is eligible for an annual long-term incentive plan. Learn more about Medtronic Long-Term Incentive Plan (LTIP) here.

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.