**POSITION SUMMARY** The Supplier Quality Engineer is responsible for managing supplier quality, and leading the CAPA program for supplier non-conformances. Coordinates and drives improvements in quality, cost, and delivery. Extensive knowledge of quality system requirements ISO 13485 & CFR 820. Relies on experience and judgment to plan and accomplish goals. Works independently with minimal supervision. **PRINCIPAL RESPONSIBILITES** + Supports supplier qualification/approval process by assessing supplier QMS as well as manufacturing and technology capabilities through onsite and virtual audit activities. + Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions. + Supports design, development, and manufacturing operations toward implementing changes within the supply base by leading the change control process for dedicated Tecomet facilities. + Partners with suppliers to establish and maintain controlled manufacturing processes. + Facilitates root cause analysis and corrective actions for supplier quality issues (SCARs). + Report supplier quality trends, performance, and other information to leadership. + Assists in contract/order reviews. + Leads efforts to reduce supply base in coordination with other Tecomet facilities. + Participates in design review for the purpose of working with suppliers to establish and maintain robust/rigorous measurement methodologies. + Supports supplier validation activities by assisting with FMEA’s and Control Plans., Special Process Validations + Performs internal audits to ensure quality compliance. + Utilize Tecomet Supplier Portal / Intranet for real-time metrics tracking with supplier. + Maintain supplier quality document repository + Perform supplier performance reviews and maintain supplier audit schedule as required. + Assists in other Quality Engineering duties as needed. + Travel up to 50% may be required. **REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES** + Regulatory cGMP, QSR and ISO knowledge base preferred. + Computer literate/proficient with Microsoft Office applications. + Negotiation and problem-solving skills. + Good oral and written communication skills; ability to properly speak and write in the English language. + Math aptitude: strong statistical skills required (DOE, SPC, Reliability, Gage R&R). + Experience in the area of manufacturing operations preferred. + Ability to multi-task, prioritize and work independently. **EDUCATION AND EXPERIENCE** + B.S. degree in Engineering preferred, or equivalent experience. + Minimum of three (3) years with medical device experience in manufacturing operations, process qualification, and/or quality engineering preferred. + ASQ Certification a plus. \#INDQA