Partners with site and QMS entity CAPA Review Boards to ensure consistent application of CAPA requirements, effective root cause analysis, risk-based decision making, and alignment of remediation activities across QMS entities.
Establishes and maintains inspection readiness strategies for the CAPA process, ensuring CAPA documentation, justifications, timelines, and evidence packages support successful regulatory inspections and third-party audits.
Drives enterprise accountability for CAPA timeliness and compliance by establishing performance expectations, monitoring overdue activities, and ensuring risk-based rationale and executive visibility for extension requests and delayed actions.
Leads identification and escalation of systemic quality and compliance risks emerging from CAPA activities, partnering with Quality, Regulatory Affairs, and business leadership to drive timely resolution.
Develops CAPA performance dashboards and executive reporting mechanisms that provide visibility into program effectiveness, compliance trends, recurring issues, inspection risks, and emerging quality concerns.
Leads and develops the MiniMed CAPA organization, ensuring appropriate capability, resource planning, process expertise, and continuous improvement to support enterprise quality objectives.
Drive the adoption and governance of AI solutions within CAPA processes to improve trend analysis, risk identification, investigation effectiveness, and continuous improvement outcomes.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelors Degree with 7+ years of quality systems experience and 5+ years experience in people management
OR
Advanced Degree with 5+ years of quality systems experience and 5+ years experience in people management
Nice To Have
Ability to evaluate, implement, and govern AI-enabled solutions within Quality Management Systems while balancing innovation, compliance, data privacy, and patient safety considerations.
Previous experience leading Quality Systems Teams within medical device industry
Experience with leading and supporting FDA inspections, other agencies and notified body audits
Experience leading large organizations in strategy and execution of quality systems
Previous experience developing global quality systems strategy
Previous experience on remediation efforts in medical device industry considerations.
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):$136,000.00 - $230,000.00 For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $150,000.00 - $256,000.00 USD.
Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
This position is eligible for a short-term incentive called the Short Term Incentive (STI).
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.
