We anticipate the application window for this opening will close on - 15 May 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

MiniMed is seeking a highly experienced Principal Quality System Specialist with specialized expertise in Recalls/Field Corrective Actions. The Principal Quality System Specialist – Recalls/Field Corrective Actions is primarily responsible for leading the planning, communication, execution, reporting, and closure of product recalls and related field corrective actions. The role serves as a 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.

Key Responsibilities

Recall Management & Execution

• Lead and oversee global product recall activities, including Class I, II, and III recalls, market withdrawals, and corrections and removals

• Serve as primary Quality SME for recall planning, initiation, assessment, execution, and closure

• Ensure recall strategies are risk-based, patient-focused, and compliant with global regulatory requirements (e.g., FDA, EU MDR, other international authorities)

• Develop recall documentation, customer notifications, effectiveness checks, and regulatory reports

• Respond to regulatory inquiries and requests for information related to recalls
  
  

Quality System & Compliance

• Maintain and continuously improve recall-related Quality System procedures and work instructions

• Ensure recall processes align with 21 CFR Part 7, 21 CFR Part 820, ISO 13485, EU MDR, and other applicable regulations and standards

• Support internal and external audits and regulatory inspections related to recalls and corrections/removals

• Assess recall-related metrics and trends to identify opportunities for systemic improvement
  
  

Cross-Functional Leadership

• Ensure accurate and timely regulatory communications and submissions

• Collaborate with Operations, Supply Chain, Commercial/Marketing, Technical Support, Medical Safety and Legal to coordinate recall execution

• Act as a mentor and technical resource for Quality professionals supporting recall activities
  
  

Risk Management & Continuous Improvement

• Provide input into CAPAs and complaint handling, related to recalls

• Drive lessons learned and preventive actions following recall activities

• Support development and deployment of recall readiness activities
  
  

Physical & Travel 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

• Occasional travel may be required (5-10%, as applicable)

Minimum Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related discipline

• Minimum of 7 years of experience in Quality, Regulatory, or related medical device functions, or advanced degree in Engineering, Life Sciences or related discipline with minimum of 5 years relevant experience

Nice to Have:

• Demonstrated hands-on experience leading or supporting medical device recalls and corrections/removals

• Strong knowledge of global recall regulations and medical device Quality System requirements

• Experience supporting global markets and interacting directly with regulatory authorities

• Proven ability to influence without authority at senior leadership levels

• Risk-based decision-making and sound judgment

• Strong written and verbal communication skills

• Cross-functional leadership and stakeholder management

• Ability to manage complex, time-sensitive issues under pressure

• High attention to detail with a strategic mindset

• Ability to work in a fast-paced, high-impact environment

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.

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.

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.