Principal Quality Systems Specialist

We anticipate the application window for this opening will close on - 5 Jun 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 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. What you’ll do: 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. Responsibilities may include the following and other duties may be assigned. Supports development 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. Supports audit and inspection preparation, resolution of audit and inspection findings through 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. Required Knowledge and Experience: 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 with Audit 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 or process improvement methodology. Six Sigma, Kaizen, PMP or other project management certification a bonus. Experience with software systems: Agile, Trackwise, Microsoft Teams, Project, PowerBI, etc. 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 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):$114,400 $143,000 $171,600 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. MiniMed Benefits Overview About MiniMed 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. Learn more about our business, and our mission here. It is the policy of MiniMed to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, familial status, membership or activity in a local human rights commission, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for MiniMed in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. MiniMed will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. 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. With a heritage rooted in technology, empathy, and a relentless pursuit of innovation, we’re focused on one thing: making every day a better day for people with diabetes. From our intelligent dosing systems that stay one step ahead to our always-on support when it’s needed most, we’re committed to building a connected system of care that works together and fits into everyday life, so people with diabetes can move through the day with fewer interruptions. Fewer second guesses. And more freedom to live in the moment. We’re here to make better days possible for people with diabetes. Joyful, messy, fully lived days. Days where things feel lighter, easier. For more than four decades, we’ve been driven by this mission, delivering groundbreaking advancements in technology to help people live more fully, freely, and with greater confidence. At MiniMed, diabetes care is personal for us. Many of our employees have a connection to diabetes, whether they're living with it themselves or through family members and friends, and we all show up each day to help make the lives of our coworkers and loved ones easier. Our people-first priority. At MiniMed, we put our customers at the forefront of all we do, and that focus extends to our team as well. We're dedicated to creating a culture of belonging and providing our people with all the career-building resources you might need. Our life-transforming technologies. No matter what your role at our company, you're making a difference in the lives of people with diabetes. Our innovative inventions improve their day-to-day by helping lift the mental load and allowing diabetes to fade into the background, empowering them to live life on their own terms. Our focus on the future. We're chasing the dream of a world where people with diabetes can be free of that never-ending battle of balancing blood sugar. A world where better days are the norm, not the exception. Fresh faces and new viewpoints will help create our cutting-edge solutions and define the next generation of breakthroughs in care, so that a better day can start today. It is the policy of MiniMed to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status.