Sr - Supplier QA Specialist

Main Objective:

To manage and maintain Arthrex supplier base to assure products and processes, internally and externally, meet specifications, while improving supplier product quality performance through PPAP and supplier collaboration, and supplier process validations in support of development and manufacturing of Class I, II and III medical devices.

Essential Duties and Responsibilities:

1. Responsible for initiating PPAPs and reviewing Supplier Part Submission Warrant (PSW) documents (pFMEA, Process Flow Diagrams, Process Control Plans, Measurement System Analysis (Gage R&R), Dimensional Results (FAIR), Capability Studies, Material Analysis Records, etc.) to ensure compliance to applicable standards (ISO 13485, ISO 17025, ISO 11737, etc.), regulations (21 CFR Part 820, EU MDR, etc.) and internal procedures.
2. Collaborate with business partners and suppliers to assist, in writing, executing, and approving IQ/OQ/PQ protocols and conducting process validations of special processes, including machining, electropolishing, anodizing, laser welding, molding, etc.
3. Responsible for reviewing Supplier Change Requests (SCR) and Supplier Proposed Process Changes (SPPC) to ensure continuous compliance to applicable standards, regulation and internal procedures.
4. Assist in the design and development of methods and tooling for the test and inspection of articles including conducting Gage R&R activities and Capability Studies.
5. Develop and revise new and existing internal and external supplier validation procedures, work instructions, and forms to insure compliance to cGMP, standards, and regulatory requirements.
6. Responsible for and assisting in compiling and reporting on supplier performance metrics / statistics and supplier development activities.
7. Evaluate and determine reduced or increased inspection plans based on supplier performance and controls.
8. Lead / participate with suppliers in the preparation of risk assessments using tools such as Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA).
9. Lead / participate with business and/or supplier partners toward improvement / development of Arthrex processes.
10. Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, Impact Assessments and other Quality Systems.
11. This role may supervise Global Supplier Quality department personnel.
12. This role may require travel up to 25% of the time.

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

• Bachelor’s degree required preferably in a Technical, Business, or Science discipline
• 9 years of Supplier Quality work experience required, preferably within a Medical Device Company

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

Knowledge of testing equipment, statistical methods, control plans, FMEA, Gage R&R and other MSA methodologies.

Knowledge of FAI / PPAP requirements

Knowledge of cGMP, ISO 13485, Regulatory, and GDP requirements.

Machine, Tools, and/or Equipment Skills:

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

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.