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The Quality Manager will provide quality system leadership to SelectTech's Springfield facilities. This position will lead activities related to optimizing the product development and manufacturing areas, maintaining the quality system, and working within the organization to expand product and process procedures and audits. This position will work on cross-functional project teams and ensure integration of the quality system throughout the entire enterprise. This position includes not only process and product quality efforts, but also equally important -- quality improvement. Expectations include: gaining an understanding of materials, product processing, assembly, development, and validation of test methods and specifications, and data analysis and experimental design. Other expectations will include: fixture design for special testing as needed, fundamental understanding of device use, component and product specification development including clinically relevant rationales, evaluation of new products and final product quality on both laboratory and large scale, and broad interaction with diverse team members. Essential Functions Establish necessary communication strategy for the improvement and awareness of quality issues across all departments - developing and maintaining an enterprise-wide quality system Build and maintain our quality system to establish standards relating to activities and products. Establish and maintain an AS9100 quality certification process Developing all relevant work instructions Managing all quality non-compliance issues Issuing all finished product quality certifications Managing and executing the return material authorization process (RMA) Compiling and analyzing statistical process control system and communicating same Monitor and inform/communicate/apply standards created/maintained by external bodies, and integrate within internal quality management systems. Report as necessary on changes in standards (internally and externally initiated) and on performance against standards. Maintain the enterprise-wide document control system for quality documents in the facility, including work instructions, audit forms, specifications, etc. Perform gauge R&R testing on various pieces of equipment. In addition, handle machine verification. Establishing and maintaining a supplier quality system Maintain Quality Problem Report (QPR) and Supplier Quality problem Report (SQP) processes Maintain incoming purchased material inspection system Perform quality audits on manufacturing operations, incoming raw materials and products, and finished products. Work on cross-functional teams for the product qualification and specification creation stage of the new product development process. Work with sales / marketing to develop product warranties and institute testing to ensure quality of product delivered to customers Develop certification and testing plans on currently existing and newly purchased equipment Able to work flexible hours as needed by the manufacturing operation. Maintains a historical warranty database of repairs and warranty issues, and calculates warranty costs based on warrantee activity. Other Duties: Please note this job description is not intended to be a complete or exclusive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Education and Experience: Bachelor's degree in a relevant engineering area, or equivalent experience is required. An advanced technical degree is a plus. Experience working in an AS9100 compliant enterprise Minimum 5 years' experience working with quality systems implementation or maintenance; vendor and process auditing; product/proc