Supplier Quality Assurance Engineer II
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. This position is responsible for the validation activities at Arthrex suppliers and provide support to internal cleaning validation.
Essential Duties and Responsibilities:
Responsible for generating and executing cleaning validation studies (product/process assessment, pFMEA, validation protocols, final reports and adoptions) ensuring compliance to applicable standards, regulations and internal procedures.
Support manufacturing, engineering, quality assurance, and quality control cleaning validation related activities.
Responsible for coordinating laboratory testing in conjunction with the 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
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.
Drive system improvement activities.
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 preferably in an Engineering or Science discipline. At least three 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:
Experience with 21CFR 820 or ISO 13485. 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.
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.