We anticipate the application window for this opening will close on - 10 Jul 2026

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):$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.

MiniMed Benefits Overview

Learn more about our business, and our mission here.