Senior Quality Engineer

The Sr./Principal Quality Engineer to ensure quality is designed into products from early development through production. This role supports product and process qualifications, risk management activities, supplier quality, production, regulatory compliance, and manufacturing transfers in accordance with applicable medical device standards and regulations. MAJOR DUTIES AND RESPONSIBILITIES Ensure quality is designed into the product from early stages of design through production. Support product qualifications such as electrical safety testing, biocompatibility, and EtO sterilization. Coordinate risk management activities, including DFMEA and PFMEA. Provide guidance to the engineering team on compliance-related activities, including software lifecycle processes. Coordinate quality activities for in-house engineering builds, including in-process inspections, final inspections, and documentation requirements. Define Receiving Inspection requirements and test methodologies. Review specifications for proper control points and develop Quality Control Plans and test methods. Participate in technology transfers to contract manufacturers. Support new product/component and process qualifications. Communicate with suppliers to resolve quality issues. Perform supplier qualifications and coordinate quality plans, PFMEAs, and process validations with vendors. May perform supplier audits and visits as needed. Lead and coordinate CAPAs and NCRs. QUALIFICATIONS & COMPETENCIES Strong knowledge of medical device GMPs, ISO 13485, and ISO 14971. Knowledge of IEC 60601 series, IEC 62304, ISO 10993, and ISO 11135 preferred. Prior knowledge in manufacturing and inspection of electronic components (PCB, PCBA, assembly processes) desired. Good understanding of GD&T and statistical analysis. Good time management and excellent communication skills. Strong attention to detail. Education & Experience BS degree in a scientific field. Minimum of 5 years of experience in Quality for medical devices. #J-18808-Ljbffr