Principal Quality Systems Specialist

remote type On-Site

locations Northridge, California, United States of America

time type Full time

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.

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.

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 Mini Med's ongoing commitment to quality excellence.

• 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.

• 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.

• 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.

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…