Senior Quality Assurance Engineer

Company: ZOLL Medical Corporation
Location: Pawtucket
Posted on: February 25, 2021

Job Description:

-- Provide technical guidance to QA and QC personnel -- Supervise personnel engaged in incoming inspection and testing activities. -- Create, document and implement inspection criteria and procedures. -- Participate in Risk Management activities -- Contribute to departmental effort in CAPA investigation and completion -- Interface with other departments to provide assistance with CAPA completion -- Represent quality interests and concerns on project teams -- Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external requirements -- Investigate causes of quality problems identified at incoming inspection, manufacturing and final QC inspection, as required -- Collect, analyze and disseminate quality data throughout the organization -- Participate in Material Review Board activities as required -- Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements -- Provide support and participate in customer and agency quality audits -- Participate in Engineering Change Order review and approval activities as required -- Four Year degree, preferably in a technical discipline, and 3-5 years related experience -- Proficiency with computers/software -- Familiarity with use of mechanical and electrical test equipment -- Knowledge of commonly used concepts, practices, and procedures related to medical device manufacturing -- Experience with ISO 13485, ISO 14971 and FDA QSR for Medical Devices Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of--activities, duties, or responsibilities that are required of the employee for this job. Duties,--responsibilities, and activities will be reviewed periodically as duties and responsibilities change--with business necessity. Essential and marginal job functions are subject to modification. ZOLL Medical Corporation appreciates and values diversity. We are an Equal Opportunity Employer M/F/D/V. ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990. Posted 26 Days Ago Full time R2723 About Us ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit www.zoll.com. The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit www.asahi-kasei.co.jp/asahi/en/. Similar Jobs Follow Us Please click here to view the ZOLL privacy policy.

Keywords: ZOLL Medical Corporation, Pawtucket , Senior Quality Assurance Engineer, Engineering , Pawtucket, Rhode Island