To manage and maintain supplier base to assure products and processes internally and externally meet specifications, and improve supplier product quality performance resulting from supplier process changes and product resourcing. This position is responsible for reviewing supplier Production Part Approval Process (PPAP) documents and for the validation activities at Arthrex suppliers.
Essential Duties and Responsibilities:
Responsible for initiating PPAP Initiation Forms and reviewing Supplier Part Submission Warrant documents (pFMEA, Process Flow Diagrams, Process Control Plans, Measurement System Analysis (Gage R&R), Dimensional Results (FAIR), Capability Studies, 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.
Responsible for reviewing Supplier Change Requests (SCR) and Supplier Proposed Process Changes (SPPC) to ensure continuous compliance to applicable standards, regulation and internal procedures.
Support manufacturing, engineering, quality assurance, and quality control process validation related activities.
Responsible for coordinating laboratory testing in conjunction with the production process and cleaning validation studies.
Responsible for performing supplier quality system and process audits.
Responsible for reviewing design drawings and processes with suppliers to assure inspectability and compliance.
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 specification.
Work with suppliers to assist, where necessary, writing and executing protocols and conducting validations as needed.
Responsible for assisting in compiling and reporting on supplier performance statistics.
Evaluate and determine reduced or increased inspection plans based on supplier performance and controls.
Initiate and assist suppliers with Corrective and Preventive Actions and assure actions are adequately closed.
Train and/or assist supplier quality personnel in inspection techniques and the use of new equipment.
Assist in the design and development of methods and tooling for the test and inspection of articles.
Work with supplier to ensure that suppliers operate in accordance with established requirements.
Write and/or assisting in writing of work instructions in conjunction with suppliers.
Responsible for assisting in complaint investigations as related to product quality from suppliers.
Drive system improvement activities.
This role requires 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 in an Engineering or Engineering Technology discipline. At least three years experience required, preferably in a Quality Control or Quality Assurance position in a Medical Device Company or Automotive Industry with strong PPAP experience.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Experience with 21CFR 820 or ISO 13485 and Production Part Approval Process (PPAP). Knowledge of testing equipment, production processes, statistical methods, control plans.
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.
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.
