Senior CAPA Quality Engineer - Medical Devices (Onsite CA)

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

Job summary

MiniMed, a leader in diabetes care technology, is seeking a Principal Quality Engineer to support CAPA programs with robust investigation and implementation of corrective and preventative actions. This on-site role requires collaboration across quality, engineering and manufacturing and may involve Northridge or San Diego sites in California.

Responsibilities include overseeing quality programs, ensuring compliant documentation, and driving cross-functional investigations and improvements.

Qualifications

• Bachelor’s degree and 7+ years medical device or pharmaceutical industry experience or Advanced degree and 5+ years of medical device or pharmaceutical industry related experience.
• 3+ years CAPA experience.

Responsibilities

• Oversee development and maintenance of quality programs, systems, and procedures to ensure compliance with internal and external standards.
• Collaborate with quality, engineering, and manufacturing to ensure quality standards and root-cause investigations are robust.
• Ensure corrective actions meet reliability standards and documentation complies with requirements.
• Prepare reports and documentation for stakeholders.
• Maintain and update QA programs and policies regularly.
• Specialize in areas of design, production control, product evaluation and reliability as they apply to quality.

Skills

CAPA experience

Root cause investigation

Regulatory audits experience

Quality mindset

Education

Bachelor’s degree in a related field

Tools

TrackWise

Quality systems software

Job description

MiniMed, a leader in diabetes care technology, is seeking a Principal Quality Engineer to support CAPA programs with robust investigation and implementation of corrective and preventative actions. This on-site role requires collaboration across quality, engineering and manufacturing and may involve Northridge or San Diego sites in California.

Responsibilities include overseeing quality programs, ensuring compliant documentation, and driving cross-functional investigations and improvements.