We are seeking a Quality Engineer to lead and facilitate the implementation of quality initiatives and continuous improvement to support the optimization and production of a new medical device. The position will develop DOE’s, validation documentation, conduct statistical analysis of data, and drive continuous improvement activities while working with a team of people comprising engineers, technicians including the customer staff. These activities will be conducted for Medical Devices – ISO13485.
Support the development and maintenance of the total QMS for the company to ensure compliance to standards, including ISO 13485 and others such as clean room standards
Develop risk assessment and mitigation plans through FMEA’s, and other risk assessment tools
Oversee equipment, process, and design validations - including generation of protocols and reports, evaluation of process capability, and providing/presenting data to responsible departments
Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence
Develops DOE’s and conducts statistical data analysis (MiniTab)
Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process SPC programs. Specific processes may include laser processes, placement accuracies, e-beam sterilization and sterile packaging.
Adheres to company’s values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. .
Performs other duties as required.
2nd shift 3PM-1:30AM
3 years experience in Medical Devices – ISO13485.
Instrumentation experience preferred with tools
Statistical based software experience preferred - Minitab
Demonstrated problem solving skills
Proficiency with the physics of lasers and optical systems
Proficiency with root cause and statistical analysis tools
Well organized with strong verbal, written and interpersonal communication skills for effectively interfacing with internal and external customers
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