Senior Quality Engineer (Electronics)

TL;DR

Senior Quality Engineer (Electronics): Designing and implementing quality standards and inspection methods for electromechanical medical devices with an accent on regulatory compliance and product qualification. Focus on developing measurement methods, conducting statistical analysis for NCR/CAPA, and ensuring adherence to ISO and IEC 60601 standards.

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.