Sr Quality Engineer - Electronics

📋 Description

• Lead and participate in projects to design, develop, and improve products, coordinating quality
• Develop and qualify new and existing products, plan phases of engineering work across scopes.
• Perform engineering work with complex features and coordinate with design control and regulatory
• Design and implement methods for inspecting, testing, and evaluating equipment; validate
• Monitor design control to ensure products meet guidelines; support developmental QA projects.
• Analyze reports and returned products; implement corrective and preventive actions (CAPA).

🎯 Requirements

• Bachelor’s degree in Engineering or related field; 5+ years QA/ISO experience, preferably in
• Advanced degree preferred; IEC 60601 experience; PFMEA; NCRs/Change Control; QA in regulated
• Experience with audits, design reviews, sterilization, project management, and PCBAs
• Working knowledge of QMS, FDA/Notified Body inspections; ability to prepare SOPs and inspection
• Strong data analysis skills; ability to lead staff development and training.
• Willingness to travel 0-10% and work in general office, lab, and cleanroom environments.

🎁 Benefits

• Competitive compensation and comprehensive benefits package; vacation and holidays; parental leave.
• 401(k) with employer match; health, dental, vision, life, AD&D, and disability insurance.
• Revolutionary mission in treatments for serious diseases and collaborative team culture.