Principal Quality Systems Specialist

MiniMed•Los Angeles, CA

2d•$121,000 - $205,000

About The Position

At 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. 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.

Requirements

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 Haves

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.

Responsibilities

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.