Engineer II - Quality Assurance Supplier Division:
Arthrex, Inc. (US01) Location:
Fort Myers, FL
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 Quality Assurance Engineer II 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. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
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 plan.
Essential Duties and Responsibilities:
- 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
- Gather and review supplier Maintenance Repair or Operating (MRO) material list to assure product risk is mitigated.
- 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.
- This role requires travel up to 25% of the time.
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 Engineering or Engineering Technology discipline.
- 2-5 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:
Knowledge of testing equipment, 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.
- Quality Management
- Quality Assurance