Principal Quality Engineer: CAPA & Med Device Expert

MiniMed; San Diego (CA); On-site; USD 121,000 - 205,000; Full time

Job summary

MiniMed is seeking a Principal Quality Engineer to lead CAPA activities and drive robust investigations, determinations, and implementation of corrective/preventive actions. This role requires on-site work 3 days/week at Northridge or San Diego, CA, and collaboration across quality, engineering and manufacturing to uphold strict quality standards.

The candidate should have a Bachelor’s degree with 7+ years in medical device or pharma, or an Advanced degree with 5+ years, and at least 3 years in

Qualifications

• 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

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.

Skills

CAPA experience

Root-cause investigation

Quality systems

Quality engineering

Education

Bachelor’s degree

Advanced degree

Tools

TrackWise

Regulatory audits

Job description

MiniMed is seeking a Principal Quality Engineer to lead CAPA activities and drive robust investigations, determinations, and implementation of corrective/preventive actions. This role requires on-site work 3 days/week at Northridge or San Diego, CA, and collaboration across quality, engineering and manufacturing to uphold strict quality standards.

The candidate should have a Bachelor’s degree with 7+ years in medical device or pharma, or an Advanced degree with 5+ years, and at least 3 years in