Job Description
📋 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.
