Principal Quality Systems Specialist

This position is responsible for the review, routing, and coordination of Change Orders within the QMS, supporting key quality processes including Periodic Review, Management Review, and audit activities. The QMS Specialist partners closely with cross-functional stakeholders - spanning Manufacturing, CAPA, Supplier Quality, Audit and Regulatory Affairs - to ensure alignment with quality system requirements and regulatory expectations. You will be coordinating Periodic Review activities and supporting Management Review and Monthly Quality Review meetings - including drafting minutes and managing follow-ups with senior stakeholders. You will serve as a key quality touchpoint for cross-functional teams, ensuring timely completion of deliverables and maintaining compliance and inspection readiness across the portfolio. Additionally, you will support internal and external audit activities as needed, contributing to MiniMed's ongoing commitment to quality excellence.

R esponsibilities may include the following and other duties may be assigned.

• Supportsdevelopment and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Supportsaudit and inspection preparation, resolution of audit and inspection findingsthrough all stages of the audits.
• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders.
• Co-ordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

We are looking for a detail-oriented, proactive professional with a strong foundation in quality regulations and standards, the ability to manage competing priorities, and the communication skills to engage effectively across all levels of the organization., * Requires a Baccalaureate degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience

• Requires experience in Quality Management Systems, including Change Management, Continuous Improvement and CAPA.
• Requires experience in usage of Microsoft office Suite - especially Word, Excel, PowerPoint, etc.

Nice to Have:

• Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.Experience in the medical device industry with relevant regulatory and standards knowledge is strongly preferred.
• Direct experience withAudit Backroom and/or Front Room roles,non-product computer system validation, regulations/standards assessment, translation coordination, and/or multi-site/QMS entity coordination would be welcome.
• May have broad knowledge of project management orprocess improvement methodology.Six Sigma,Kaizen, PMP or other project management certification a bonus.
• Experience with software systems: Agile, Trackwise, Microsoft Teams, Project, PowerBI, etc.

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 offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

Salary ranges for U.S (excl. PR) locations (USD):$121,000 - $205,000

For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $121,000 - $205,000 USD.

At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that "regular employees" refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico.

For further details about our comprehensive benefits, we encourage you to visit the link below.

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., MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey - when and how they need it. For more than 40 years, we've been committed to redefining what's possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always on support when it's needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes.