Prin Quality Systems Spec - CAPA

MiniMed•Los Angeles, CA

1d•Hybrid

About The Position

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 our Northridge, CA.

Requirements

Requires a Baccalaureate degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience

Nice To Haves

Mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience
May have broad knowledge of project management

Responsibilities

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 assure 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