<p>Duties and Responsibilities</p> <ul> <li>Collect, analyze, and summarize data, turning it into useful information, then use that information to drive continuous improvement actions </li><li>Establish and implement effective process controls and product test requirements </li><li>Select appropriate sampling plans for evaluating product/process quality </li><li>Monitor product performance and institute methods to reduce variability </li><li>Establish statistical process capability for all manufacturing processes; evaluate precision and accuracy of production equipment </li><li>Perform failure analysis and ensure that timely corrective/preventive action is taken </li><li>Collect, review, and analyze production data with manufacturing and product development teams and report quality issues, trends, and losses to management </li><li>Use appropriate quality tools to solve problems identified during quality assurance activities </li><li>Provide appropriate input to Engineering Change activities </li><li>Develop standards and methods for inspection, testing, and evaluation of products and processes </li><li>Provide training and coaching to Inspection personnel </li><li>Ensure that appropriate testing, measurement, and analytical equipment and methodology are used for quality assessment; serve as a metrology resource </li><li>Lead Corrective and Preventive Action (CAPA) activities, including root cause investigations, and corrective actions in response to internal nonconformities and customer complaints </li><li>Develop and implement methods and procedures for the disposition of nonconforming material; define methods to assess the cost of non-conformities </li><li>Participate in internal, external, and supplier audits and determine proper corrective and preventive actions, along with bringing audit findings to closure </li><li>Assist with new product development activities, including supplier selection, product and process risk assessments, Operations training, drawing interpretation, and Control Plan development to ensure that expectations for quality, performance, regulatory compliance, and delivery are met </li><li>Communicate significant issues or developments identified during quality assurance activities and provide recommendations for improvements </li><li>Participate in process verification and validation activities according to FDA/CE/Health Canada and all other global regulatory agency requirements (IQ, OQ, PQ) </li><li>Maintain database of supplier contract templates and agreements, manage Supplier Non-conformances and Supplier Corrective Actions </li><li>Monitor and drive continuous improvements of current suppliers </li><li>Lead or assist implementing Quality Controls and Supplier verification activities for incoming receiving inspection </li><li>Ensure and assist suppliers at maintaining regulatory compliance and review/define the necessary documentation, registration, and certification per category of suppliers (OBL, Distributor, Contract Manufacturer, etc.) </li><li>Perform additional responsibilities as requested to achieve business objectives </li></ul> <p>Qualifications</p> <ul> <li>BS or BA degree in Mechanical, Industrial, or Manufacturing Engineering, Quality, or a related field, with 2-5 years' experience as a Quality Engineer </li><li>Experience with medical devices or other highly regulated industries/products desired </li><li>Demonstrated understanding of metrology, calibration, and inspection techniques </li><li>Demonstrated understanding of data-driven Quality tools such as SPC, CPK, Gage R & R, and problem-solving methodologies (e.g., 8D, 6 Sigma, 5-Why), and ability to teach the use of such tools to a wide range of associates </li><li>Demonstrated ability to work and make decisions independently and lead others to the completion of assigned tasks </li><li>Basic understanding of regulatory requirements for medical device design control and manufacturing is strongly desired </li><li>Demonstrated ability to communicate effectively both verbally and in written form; Record of establishing good working relationships with all manufacturing, design, material control and supplier personnel </li><li>Strong computer skills including QA applications (such as Minitab), word processing, spreadsheets, databases and ERP software. </li><li>Demonstrate strong internal structure to successfully lead multiple activities simultaneously </li><li>ASQC CQE certification preferred </li><li>Desire to maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, benchmarking state-of-the-art practices, participating in professional societies, and pursuing relevant certifications </li></ul> <p>Physical Requirements:</p> <ul> <li>Must be able to sit, stand, and/or walk for up to 8-10 hours per day </li><li>Must be able to occasionally lift up to 25 pounds </li><li>May require occasional early morning or late evening teleconferences </li><li>May require occasional visits to suppliers </li></ul>