Principal Quality Engineer

About The Role

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.

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.

Must Have

• 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 Have

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

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package. Salary ranges for U.S (excl. PR) locations (USD): $109,000.00 - $185,000.00. For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $121,000 - $205,000 USD. Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location.

This position is eligible for a short-term incentive called the Short Term Incentive (STI). Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.