Engineer II - QA ACT

Arthrex, Inc.is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex isactively searching for an Engineer II - QA for our Santa Barbara, CA location. The Engineer II is r esponsible 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 a Bachelors degree in Engineering and 2 years experience in Quality Control or Quality Assurance. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Betterandtrade;. Essential Duties and Responsibilities: 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. Reports progress and status of assigned projects on a timely basis with emphasis on reporting results to Quality Assurance Management, - ACT Participates with multifunctional new product project teams in developing risk assessments, design inputs, test and inspection procedures, acceptance criteria, and complaint analysis. Utilizes problem-solving tools and techniques and applies a risk-based approach to problem-solving. Determines the 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. Approves manufacturing and repair product and process changes and assures the change management is controlled, adequate, and documented. Ensures information and documentation is consistently accurate. Responsible for NCR activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations. Provide input and direction to other members of the quality assurance department to assist them in their assignments and provide them with a learning experience. Work with manufacturing and service engineers to troubleshoot failures, repairs, and device evaluations. Education and Experience: Bachelors degree in Engineering required 2 years experience in Quality Control or Quality Assurance related activities; preferablyin 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, PFMEAs, control plans, quality plans, testing and inspection equipment and techniques as they relate to their device responsibilities. Manufacturing process knowledge. Technical knowledge in development methodologies, design, and project implementation, including, but not limited to GDandT, DOE, verification, and validation. SPC (Statistical Process Control) knowledge is preferred. Understanding of applicable medical device regulations for electrical safety and EMI/EMC Strong communication skills and ability to communicate effectively with technical and non-technical staff. Project management skills preferred. Recognized process improvement (i.e.: Lean, Six Sigma) and problem-solving (i.e.: RCA, DMAIC, 5 Whys) training preferred. Quality/Manufacturing/Design Assurance Experience with Medical Capital Equipment.[]{_Hlk143241107} Thorough knowledge of FDA, ISO13485 and CMDR Quality System Requirements, ISO 14971 Risk Management Standard to medical devices, EN60601, medical equipment safety and EMC, and RoHs Directives. []{style"font-size: 11pt; font-fami "}