Engineer Tech - QA - Night Shift at Arthrex Manufacturing, Inc. in Pendleton, South Carolina

Job Description:

Requisition ID: 55795 Title: Engineer Tech - QA - SC - Night Shift Division: Arthrex Manufacturing Inc (US02) Location: Pendleton, SC

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Quality Assurance Engineer Tech. This position will support our night shift (Monday through Thursday, 7:30 pm to 6 am). Successful candidates must possess a minimum of a high school diploma. Previous experience in a quality control or quality assurance role is required, with 5 (five) or more years being strongly preferred. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

This position is responsible for supporting the Quality Engineering department with activities related to the life cycle of Class I and II medical devices encompassing new product development and support of established product lines.

Essential Duties and Responsibilities:

• Represent Quality Assurance in design control activities as part of cross functional design development teams for Class I and II devices as assigned by Quality Management based on experience.


• Initiate and coordinate risk assessment activities in accordance with Quality System requirements.


• Responsible for reviewing design drawings for inspect-ability, manufacturability, and quality of design issues.


• Develop standard methods for inspection, testing, and evaluation, utilizing knowledge from related engineering fields.


• Assist and support in developing gauging, fixtures and tooling for the test and inspection of articles, and test and inspection procedures


• Assist in the training of QC Inspectors on inspection techniques and the use of new equipment


• Provide support to internal and external suppliers to mitigate quality related issues and facilitate process improvements.


• Responsible for working with design and manufacturing engineering to prevent quality discrepancies and help determine the root cause and drive corrective actions with guidance of quality engineers.


• Facilitate the review and disposition of manufacturing and supplier related nonconformances and deviations


• Perform post market surveillance activities for assigned product lines which may include, complaint investigations, complaint trending, and initiating corrective and preventative actions as required.


• Assist Quality, Regulatory, and R&D in periodic inspection and testing of devices to support ongoing engineering studies.


• Perform data extraction and analysis to quantify quality metrics for assigned projects. May involve presenting data to engineering groups.


• Participate in Internal and External quality audits as directed by the Quality Management.

Education and Experience:

• High school diploma required


• 5 years' experience in a Quality Control or Quality Assurance position preferred


• Post-secondary education preferred

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

Experience working within a regulated industry providing exposure to Quality Systems, Design Control, Change Control, CAPA, Risk Management, Post market surveillance etc. Undergraduate courses in related areas may substitute for experience.

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.