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Supplier Quality Engineer II

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Utica, United States CONMED Corporation Full time

The Supplier Quality Engineer II (SQE) is responsible for managing the quality of products provided by suppliers and contractors to CONMED and ensuring compliance to regulations by ensuring adherence to proper purchasing controls including the procedures for supplier qualification, part qualification, nonconformance management, supplier corrective actions, and supplier performance monitoring. The SQE II supports sourcing of purchased items through an assessment of supplier capabilities and the successful completion of component qualifications that verify manufacturing capabilities. During new product development activities, the SQE II provides guidance on inspection methods and works closely with Inspection services to conduct Measurement Systems Analysis (MSA) and establish correlation with the supplier. SQE II also works closely with purchasing, manufacturing, and the supplier to facilitate issue resolution for non-conformances, and to ensure effective root cause corrective actions are implemented to prevent recurrence. This is an onsite position in Utica, NY. Duties and Responsibilities: • Supports issue resolution for purchased items and provides risk assessment and final disposition of non-confirming product • Supports development of new purchased products including specification requirements and risk documentation • Facilitates and approves supplier component qualifications, including process validations, to verify implementation of acceptable inspection techniques, manufacturing process controls and Quality System controls. • Works with supplier and receiving inspection to develop and correlate robust inspection methods and fixtures as required. • Creates and updates Receiving Inspection Plans. • Supports Supplier Change Requests and facilitates impact assessment and plan development • Requests and verifies successful completion of First Article Inspections during part qualifications. • Manages/conducts supplier audits (on-site or desk) and verifies completion of identified supplier corrective actions (SCARs). • Maintains records for coordination of Quality System reporting • Identifies and implements QS processes improvement opportunities Requirements: • Bachelor's degree • 2+ years of professional work experience Preferred Knowledge requirements: • Knowledgeable of medical device Quality System Requirements and an understanding of compliance with FDA CFR 21 part 820, GMP and ISO 13485 • ASQ certifications (CQA, CQE) • Ability to read and understand engineering drawings. Understanding of GD&T specifications and how they translate to measurement methods • Capable of implementing statistical methods and techniques for process controls and data analysis • Understanding of the practical application and capabilities of various types of inspection equipment, including hand tools (fixed gauges, micrometers, calipers) and programable touch and vision systems (CMM, DVM) and similar equipment • Experience and/or training with DMAIC problem solving techniques • Understanding of various manufacturing processes including machining, molding, forming, coatings, and various surface treatments Travel Expectations 0-20%

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