Supplier QA Engineer II

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Supplier QA Engineer II who will work directly with the QA Engineering departments within Arthrex to manage and maintain supplier base to assure products and processes internally and externally meet specifications, improve supplier product quality performance, and determine adequate receiving inspection plans.  Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree in Engineering or Engineering Technology will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Investigate, document, and resolve supplier-related nonconformances impacting the Arthrex California Technologies (ACT) site.
• Work closely with ACT Sustaining Quality Engineers to support the manufacturing of Camera Systems and related electronic medical devices.
• Help assure that outsourced materials conform to all requirements as specified on Engineering Drawings.  
• Partner with external suppliers to ensure containment of nonconformances.
• Issue formal supplier corrective action requests requiring structured corrective and preventative action (CAPA) problem-solving techniques utilizing 5-whyY, Fishbone Analysis, and other scientific techniques to assure effective permanent resolutions.
• Track Corrective Actions issued to suppliers to assure timelines are met.  
• Compile, analyze, and report on supplier performance metrics.
• Help to enforce Arthrex established requirements within the supplier base.
• Train and assist suppliers in inspection techniques and the use of new equipment.
• Work with suppliers to improve product and process quality and assist with correlations studies and inspection plans.
• Review supplier processes and process validations to assure internal and external processes are adequate to meet specifications.
• Work with suppliers to assist in writing and executing protocols and conducting validations as needed
• Write and assist in the writing of work instructions in conjunction with supplier processes
• Responsible for assisting in customer complaint investigations related to supplier product quality.
• Responsible for reviewing design drawings and processes with suppliers to assure inspectability and compliance.
• Evaluate and determine reduced or increased inspection plans based on supplier performance and controls.
• Support both internal and supplier quality audits as needed.

Education and Experience:

• Bachelor’s degree required an Engineering or Engineering Technology discipline.
• 2+ years experience required, preferably in a Quality Control or Quality Assurance position in a Medical Device Company.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Working knowledge of PPAP/Component Qualification-related tools and techniques like Process Flow Diagrams, PFMEAs, APQP, Control Plans, Measurement Systems Analysis, Capability Studies, Test equipment, Advanced statistical methods,

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Minitab,  Excel, Word (or equivalents if changed by the Company), SAP or similar inventory software.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. 

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.