Manufacturing Quality Engineer Job in New Brighton 55112, Minnesota US
Job Summary:
Manufacturing QA Engineers participate on teams to support the manufacturing of complex electronic and software based medical devices. This includes working with suppliers of circuit board assemblies 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.
Essential Duties and Responsibilities:
§ Provide quality engineering support for manufacturing, such as problem resolution, product and process improvements and documentation development.
§ Review and approve engineering changes orders (ECOs) for products in manufacturing.
§ 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.
§ Contribute to the overall improvement in systems and processes.
§ Support the quality system audit program.
§ Assist with other technical tasks as requested.
Qualifications:
§ BS degree in an engineering, technical or scientific discipline is preferred.
§ Must have education, training and 3-5 years of job experience performing quality engineering support for manufacturing electronic and software based medical devices.
§ A working knowledge of electronic test equipment for functionally testing circuit board assemblies and finished devices is a plus.
§ Must have a solid understanding of ISO 13485:2003 and the FDA Quality System Regulation in a manufacturing environment.
§ Must have working knowledge of supplier quality management specifically, circuit board assembly’s suppliers.
§ 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.