Prin Quality Systems Spec
$114,400 - $171,600 per year
Key Skills
Job Description
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
MiniMed is seeking a highly experienced Principal Quality System Specialist with specialized expertise in Recalls/Field Corrective Actions is primarily responsible for leading the planning, communication, execution, reporting, and closure of product recalls and related field actions. The role serves as the Quality System subject matter expert for recalls, ensuring timely, compliant, and effective coordination across cross‑functional teams and regulatory authorities to protect patients, customers, and the company.
Join a passionate team dedicated to transforming diabetes care through innovative sensor technology. You’ll have the opportunity to make a meaningful impact on patients’ lives and work with some of the brightest minds in the medical device industry.
Responsibilities may include the following and other duties may be assigned.
Provides oversight for the 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
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external
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 mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience
Requires a Baccalaureate degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience
Nice to Have:
May have broad knowledge of project management
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.
Core Responsibilities
The Principal Quality System Specialist leads the planning, execution, and closure of product recalls and field corrective actions. They also provide oversight for quality programs and ensure compliance with internal and external regulatory standards.
Requirements
The role requires a Baccalaureate degree with at least 7 years of relevant experience, or an advanced degree with at least 5 years of experience. Mastery of quality systems and industry practices within the medical device sector is essential.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Health savings account
- Healthcare flexible spending account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Incentive plans
- 401(k) plan with company match
- Short-term disability coverage
- Paid time off
- Holidays
- Employee stock purchase plan
- Employee assistance program
- Non-qualified retirement plan supplement
- Capital accumulation plan
About MiniMed
Industry: Medical Equipment Manufacturing
Company size: 5,001-10,000 employees
MiniMed is a full-stack insulin delivery company built around one belief: that technology should lift the burden of diabetes. So that every day is a better day. Days when diabetes fades into the background and life takes the lead. Joyful, messy, fully lived days — when things feel lighter, easier, more possible. Those are the days we’re here to make real. Connect with us! Facebook @ www.facebook.com/MiniMed Instagram @ www.instagram.com/minimed/ X @ https://x.com/minimed TikTok @ https://www.tiktok.com/@minimed YouTube @ https://www.youtube.com/@MiniMed_US