Principal Quality Engineer (Medical Devices)

Location: Hybrid, with 3 days on-site at the Northridge or San Diego, California, United States site.

Salary: $121,000–$205,000 USD annually for California locations.

Company

hirify.global develops intelligent insulin delivery systems, predictive insights, and support solutions for people living with diabetes.

What you will do

• Lead and support CAPA programs, including robust investigations and implementation of corrective and preventive actions.
• Oversee the development and maintenance of quality programs, systems, processes, and procedures.
• Collaborate with quality, engineering, and manufacturing functions on quality standards and cross-functional root-cause investigations.
• Verify that corrective measures meet reliability standards and that documentation complies with applicable requirements.
• Prepare reports and documentation for internal and external stakeholders.
• Maintain and regularly modify quality assurance programs and policies, with possible specialization in design, production control, product evaluation, reliability, or research and development.

Requirements

• Bachelor’s degree plus 7+ years of medical device or pharmaceutical industry experience, or an advanced degree plus 5+ years of medical device or pharmaceutical industry experience.
• 3+ years of CAPA experience.
• Ability to work three days on-site at the Northridge or San Diego, California site.

Nice to have

• CAPA and root-cause investigation experience.
• TrackWise software experience.
• Experience supporting regulatory audits.
• Quality engineering background in medical devices.

Culture & Benefits

• Full-time employment with competitive compensation and flexible benefits.
• Health, dental, and vision insurance, plus Health Savings Account and Healthcare Flexible Spending Account access.
• Life insurance, disability coverage, paid time off, and paid holidays.
• 401(k) plan with company match, Employee Stock Purchase Plan, and Employee Assistance Program.
• Eligibility for short-term incentive plans and certain additional retirement and capital accumulation plans.