Principal Quality Engineer

MiniMed•San Diego, CA

2d•$121,000 - $205,000•Hybrid

About The Position

The Principal Quality Engineer will support CAPA programs particularly focused on robust investigation as well as determination and implementation of corrective and preventative actions. This role requires you to work 3 days on-site at one of these US sites: Northridge or San Diego, CA.

Requirements

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.

Nice To Haves

CAPA and root cause investigation experience
Trackwise software experience
Experience supporting regulatory audits
Quality engineering background for medical devices

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.
Collaborates with quality, engineering and manufacturing functions to ensure quality standards are in place and supports rigorous cross-functional root-cause investigation.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Prepares reports and/or necessary documentation provided to applicable stakeholders, both internal and external.
Ensures the quality assurance programs and policies are maintained and modified regularly.
May specialize in the areas of design, production control, product evaluation and reliability, and/or research and development as they apply to product or process quality.