Principal Quality Systems Specialist

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. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

Responsibilities

• Review, route, and coordinate Change Orders within the QMS, supporting key quality processes including Periodic Review, Management Review, and audit activities.
• Partner closely with cross-functional stakeholders — spanning Manufacturing, CAPA, Supplier Quality, Audit and Regulatory Affairs — to ensure alignment with quality system requirements and regulatory expectations.
• Support Periodic Review activities and assist in Management Review and Monthly Quality Review meetings, including drafting minutes and managing follow-ups with senior stakeholders.
• Coordinate internal and external audit activities as needed, contributing to MiniMed's commitment to quality excellence.
• Support 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.
• Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Prepare reports and/or necessary documentation (Corrective and Preventative Actions) and provide to applicable stakeholders.
• Co-ordinate legal requests in support of government investigations or litigations.
• Ensure the quality assurance programs and policies are maintained and modified regularly.
• Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of company's mission globally.

Requirements

• Baccalaureate degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
• Experience in Quality Management Systems, including Change Management, Continuous Improvement and CAPA.
• Experience in usage of Microsoft office Suite – especially Word, Excel, PowerPoint, etc.

Qualifications

• Mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
• 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.
• 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.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package. For further details about our comprehensive benefits, we encourage you to visit the link below.

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.