Medical Device Quality Engineer

Defibtech, LLC:

Defibtech, LLC is a leading innovator in the field of Automated External Defibrillators (AEDs). The company designs and manufactures?automated external defibrillators and related accessories. Products are sold exclusively through a network of distribution partners in the United States and around the world.


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Medical Device Quality Engineering Consultant
The Medical Device Quality Engineering Consultant will be responsible for supporting product and process quality improvement for a Medical Device Company manufacturing software driven class III devices in a cGMP environment. Activities include leadership and support in corrective and preventive action initiation and implementation, defect data analysis to identify and support process and product improvement, and support of cross-functional quality improvement teams.


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Responsibilities Include:Supporting process and product yield improvement on factory floor Supporting initiation and closure of preventive and corrective actions Technical field failure investigation support for factory related failures Conducting process and internal audits to identify improvement opportunities and maintaining the management system Assisting with quality related operator technical training Interfacing with supplier quality engineering and new product development for supplier and product design improvements Supporting and maintaining business quality performance metrics Supporting quality issues on manufacturing floor Recommending test and inspection requirements and strategies


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Job Requirements:BS required 4+ years quality engineering experience Certified Quality Engineer (CQE, ASQ) desired Strong and thorough knowledge of quality engineering discipline, including: Quality data collection and charting Quality planning Cost of poor quality Statistical methods, including sampling Inspection methods and tools, mechanical and electrical Training Quality Systems development, maintenance, and auditing (ISO 13485) Process and internal auditing Interpretation of technical drawings Material control Reliability and maintainability