Senior Quality Engineer (Electronics)

TL;DR

Senior Quality Engineer (Electronics): Develop and maintain quality standards for manufacturing electronics in medical devices with an accent on design control, inspection methods, and regulatory compliance. Focus on leading qualification activities, performing statistical analysis, analyzing failures, and supporting FDA inspections and audits.

Alameda, CA

$125,000 to $175,000

Company

Global healthcare company focused on innovative therapies for challenging medical conditions.

What you will do

• Lead quality efforts in product development, qualification, and continuous improvement projects.
• Design and validate inspection, testing, and measurement methods for precision equipment.
• Monitor design control, analyze reports and returns, recommend corrective/preventive actions.
• Perform statistical analysis, participate in NCR/CAPA processes, and support audits/inspections.
• Develop SOPs, prepare documentation, and train staff on QSR.
• Select, manage, and develop quality team members.

Requirements

• Bachelor’s degree in Engineering, Life Science or related field with 5+ years relevant experience in Quality Assurance and ISO, preferably in medical devices.
• Experience with Electronic devices, PCBAs, and Contract Manufactured Electromechanical Medical device products.
• Knowledge of Process Failure Mode and Effects Analysis (PFMEA), NCRs, Failure Investigations, and Change Control.

Nice to have

• Advanced degree.
• Experience applying IEC 60601 standards.
• Experience in auditing, design review, sterilization, project management, or product development.

Culture & Benefits

• Collaborative teamwork environment with constant learning and performance rewards.
• Medical, dental, vision, life, AD&D, short/long-term disability insurance.
• 401(k) with employer match, paid parental leave, 11 paid holidays, 15+ days vacation increasing with tenure, paid sick time.
• Business travel 0-10%, general office/lab/cleanroom environments.