Principal Quality Systems Specialist - CAPA

remote type Flexible

locations Northridge, California, United States of America Minneapolis, Minnesota, United States of America San Diego, California, United States of America

time type Full time

We anticipate the application window for this opening will close on - 4 Aug 2026

At Mini Med, 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.

The Principal Quality System Specialist - CAPA will assist with all aspects of the CAPA process, through investigation, helping to determine corrective and preventive actions and effectiveness checks, monitoring action implementation, and completion of effectiveness checks, while working in the electronic CAPA system.

This role requires you to work 3 days on-site at one of these US sites:
Northridge, CA, San Diego, CA or Minneapolis, MN.

• 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 ensure 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.

• Bachelor’s degree and 7+ years of medical device or pharmaceutical industry related experience or Advanced degree and 5+ years of medical device or pharmaceutical industry related experience.
• 3+ years CAPA experience.

• Trackwise software experience
• Experience supporting regulatory audits
• Quality engineering background
• Project Management experience

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.

At Mini Med, 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):$ - $

For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the base…