Senior Quality Engineer (Electronics)

Location: On-site in Alameda, CA

Salary: $125,000 – $175,000

Company

hirify.global is a global healthcare company focused on innovative therapies for challenging medical conditions.

What you will do

• Lead project teams to design, develop, and continuously improve quality efforts for new and existing products.
• Implement methods and procedures for inspecting, testing, and evaluating equipment precision and accuracy.
• Monitor design control to ensure products meet regulatory guidelines and industry standards.
• Analyze reports and returned products to recommend corrective and preventive actions (CAPA).
• Perform statistical analysis to determine responsibility for materials not meeting specifications.
• Support FDA and notified body audits and assist in QSR training.

Requirements

• Bachelor’s degree in Engineering, Life Science, or a related field.
• 5+ years of experience in Quality Assurance and ISO, preferably in the medical device industry.
• Experience with Electronic devices and/or PCBAs.
• Knowledge of PFMEA, NCRs, Failure Investigations, and Change Control.
• Must be based in or able to work on-site in Alameda, CA.

Nice to have

• Advanced degree.
• Experience applying IEC 60601 standards in a medical device environment.
• Experience in auditing, sterilization, or project management.
• Experience with contract manufactured electromechanical medical products.

Culture & Benefits

• Collaborative teamwork environment with constant learning opportunities.
• Comprehensive benefits including medical, dental, vision, and life insurance.
• 401(k) with employer match.
• Paid parental leave and 11 paid company holidays per year.
• Minimum of 15 days of accrued vacation, increasing with tenure.