QA Engineer II - Design

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Quality Engineer who would be Responsible for various Quality Assurance functions and design development activities of Class I and II medical devices in compliance with FDA, ISO, CMDR Quality Systems and Design Control requirements. This position requires leadership skills, the willingness and ability to mentor junior Quality Engineers and Quality Assurance Inspectors as well as contributions beyond objectives and expected performance. Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree in Engineering, or related Engineering Technology discipline will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

1. Participates in the design of medical devices and components from design initiation through design transfer by representing Quality Assurance in all design and development project teams.
2. Participates with multifunctional new product project teams in developing risk assessments, design inputs, test and inspection procedures, acceptance criteria and complaint analysis.
3. Determines necessity of testing and initiates testing of assigned products by preparing test and inspection plans, and, identifying and obtaining required test fixtures and test/inspection instrumentation.
4. Leads NCMR and MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations.
5. Provides input and direction to other members of the quality assurance department to assist them in their assignments and provide them with learning experience.
6. Assists in the maintenance of design history files for assigned projects, adhering to Arthrex design control procedures and performing periodic reviews of design history files to assure timely design transfers.
7. Supports manufacturing suppliers through selection and approval, audits, corrective and preventive actions, assistance in on-site resolution of quality and process related issues.
8. Reports progress and status of assigned projects on a timely basis with emphasis on reporting results to Quality Assurance Manager, - ACT

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 in Engineering required
• 3 years’ experience in a Quality Assurance Engineering position required;  preferably in a Medical Device Company.
• Experience with medical device capital equipment and software validation preferred.

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

Working knowledge of risk assessments, design control requirements, testing and inspection equipment and techniques as they relate to their device responsibilities. Sufficient proficiency in drawing changes using a 3D-CAD program to add, modify and delete quality requirements. Manufacturing process knowledge. Technical knowledge in development methodologies, design, and project implementation, including, but not limited to GD&T, DOE

Thorough knowledge of FDA, ISO13485 and CMDR Quality System Requirements, ISO 14971 Risk Management Standard and IEC 62366 Application of Usability engineering to medical devices, EN60601, medical equipment safety and EMC, RoHs and WEEE Directives.

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.