Quality Engineer - Medical Device Defibtech, LLC -
Guilford, CT
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. Defibtech has been named one of the fastest growing technology companies in Connecticut four years in a row.
The Defibtech Quality Engineer 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.
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
Job Requirements:
BS required
4+ years quality engineering experience
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
Experience with a variety of manufacturing/production processes preferred
Dice - 2 years ago
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