Supplier Quality Engineer II

The Supplier Quality Engineer (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 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 provides guidance on inspection methods and works closely with Inspection services to conduct Measurement Systems Analysis (MSA) and establish correlation with the supplier. SQE 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. 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 or equivalent • 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) a plus • Ability to read and understand engineering drawings required. 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 Expected travel 20% - 30% This position is not eligible for employer-visa sponsorship. Benefits: CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information. Competitive compensation Excellent healthcare including medical, dental, vision and prescription coverage Short & long term disability plus life insurance -- cost paid fully by CONMED Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period Employee Stock Purchase Plan -- allows stock purchases at discounted price Tuition assistance for undergraduate and graduate level courses Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives! CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, citizenship status, or veteran status. If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3. CONMED Corporation is a progressive, global medical device company. Through thoughtful leadership, innovation and team work, we are changing the future of medicine. Our 3,500 employees worldwide make meaningful contributions, positively impact the business, and advance in their careers as our company and product portfolio grows. We are a leader in Orthopedics, General Surgery, Gynecology, Gastroenterology, Pulmonology, and Anesthesiology and our employees enjoy challenging and diverse job opportunities across these varied specializations. We are headquartered in upstate New York with additional domestic facilities in FL, CA, MA, CO, and GA. We have an international presence in more than 20 locations throughout Europe, Australia, Latin America, Asia, North America, and the Middle East.