US-MN-Saint Paul: Quality Assurance Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 04-Jul-2008

Quality Assurance Engineer

Qualifications: Must have education, training and 2 to 7 years of job experience performing quality engineering support for manufacturing electronic and software-based medical devices. Candidate must have a solid understanding of ISO 13485:2003 and FDA Quality System regulations within a manufacturing environment. Must have working knowledge of supplier quality management, specifically with circuit board assembly suppliers. A bachelor’s degree in an engineering, technical or scientific discipline is preferred. A working knowledge of electronic test equipment for functionally testing circuit board assemblies and finished devices is a plus. Successful candidates will be proficient at supporting multiple product lines in manufacturing and have a working knowledge of quality improvement tools, techniques and measurement systems.

Responsibilities: The Manufacturing Quality Assurance Engineer will participate on teams to support the manufacturing of complex electronic and software based medical devices. They will also be involved in working with suppliers of circuit board and custom mechanical assemblies. This position will also support the quality system maintenance and improvement activities. They will develop test and inspection methods for the devices in manufacturing to ensure that they meet product requirements and specifications.

Tasks include:

* Provide quality engineering support for manufacturing, such as problem resolution, product and process improvements and documentation development * Review and approve engineering change orders for manufacturing products * Participate in customer meetings during ongoing product reviews * Perform process FMEAs and qualifications * Support the supplier management process including selection, approval and problem resolution to ensure parts and components delivered meet specifications * Participate in the identification and maintenance of appropriate metrics to assess the effectiveness of the manufacturing processes and the quality system * Develop inspection/test fixtures and equipment to support receiving and final inspection * Coordinate and participate in elements of investigations regarding customer complaints * Support the quality system audit program * Assist with other technical tasks as requested

Quality Assurance personnel are encouraged to be creative and innovative, while at the same time are expected to learn and follow our structured processes. They will take direction from engineers and other technical personnel and will assume appropriate level of responsibility for technical work to assist in the development or manufacturing of products or assemblies.

Quality Assurance personnel are expected to contribute to our team while enhancing their own technical expertise and increasing their responsibilities.

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com