Senior Quality Systems Specialist

MiniMed Group; California; On-site; USD 87,000 - 149,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Dental insurance

Vision insurance

401(k) match

Stock purchase plan

Job summary

MiniMed is seeking a Senior Quality Systems Specialist in Northridge, CA to lead and optimize our quality management system across manufacturing, CAPA, supplier quality, and regulatory affairs. You will review changes, drive process improvements, prepare audit materials, and partner with cross-functional teams to ensure compliance with internal policies and external standards.

The role emphasizes data-driven decision making, effective communication, and proactive risk management, with

Qualifications

• 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.

Responsibilities

• Reviews and facilitates 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 to co-workers 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 and provides to applicable stakeholders, both internal and external.
• Leads or supports compliance related activities like audit readiness, Corrective and Preventative Actions (CAPA), process improvement.

Skills

Quality Management Systems

Change Management

CAPA

Regulatory Affairs

Data analysis

Education

Bachelor's degree

Tools

Trackwise

PowerBI

Project

Excel

Word

Job description

## Senior Quality Systems SpecialistApply: On-Site: Northridge, California, United States of America: Full time: Posted Yesterday: End Date: November 3, 2026 (12 days left to apply): R-802171We anticipate the application window for this opening will close on - 3 Nov 2026At 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. The Senior 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. **A Day in the Life*** Review and drive QMS changes to support product and process releases and updates, sourced from local and enterprise level. Use excellent verbal and written communication skills to communicate and collaborate.* Build and maintain positive relationships across the organization with strong relationship skills and act as a quality partner to other groups.* Coordinate with team members, manager and other stakeholders to support both day-to-day activities and long-term goals.* Contribute to QMS quality by identifying, collaborating, creating and/or completing process improvements changes.* Support monthly and quarterly quality metric reviews (as well as others) by facilitation, communicate, review and recording.* Use critical thinking and data analysis to identify outliers or concerns and act to resolve. **Responsibilities may include the following and other duties may be assigned.*** Reviews and facilitates 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 to co-workers 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 and provides to applicable stakeholders, both internal and external.* Leads or supports compliance related activities like audit readiness, Corrective and Preventative Actions (CAPA), process improvement* May act as back-up for software validation or other quality activities as needed.* 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:*** Mastery of a specialty area and 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):$87,000.00 - $149,000.00 For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $87,000 - $149,000 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.