Supplier Quality Assurance Engineer
Sandy Springs, SC
This position will be located at the Arthrex manufacturing facility in Sandy Springs, SC. The successful candidate for this position must be able to attend initial training in the Naples, FL area if needed by 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 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 in an Engineering or Engineering Technology discipline required. At least three years of related 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.
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), SAP or similar inventory software.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Ability to comprehend and