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 Sr. I - QA for our Santa Barbara, CA location. The Engineer Sr. I QA 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 5+ years experience in a QC or QA position.

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 development of medical devices and components from design (and/or design improvement) initiation through design transfer and by representing Quality Assurance for manufacturability in assigned design and development project teams.
• Reports progress and status of assigned projects on a timely basis with an emphasis on reporting results to Quality Assurance Management, - ACT
• Participate in all manufacturing and repair activities to assure compliance with design specifications.
• Utilizes problem-solving tools and techniques and applies a risk-based approach to problem-solving.
• Determines the necessity of testing and initiates testing by preparing test and inspection plans, and identifying and obtaining required test fixtures and test/inspection instrumentation.
• Initiates new projects and acts as the project leader for key initiatives, and identifies best practices.
• Performs quality trending and leads/supports process improvement initiatives.
• 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, and issuing and/or monitoring corrective actions associated with nonconformance and deviations.
• Provides input and direction to other members of the quality assurance department to assist them in their assignments and provide them with a learning experience.
• May supervise other engineers, quality specialists, and support personnel.
• Analyzes repair data using statistical analysis tools to identify any adverse trends, and makes recommendations on actions that can be taken to reverse such trends.
• Work with Manufacturing Engineers and Service Engineers troubleshooting failures, repairs, and evaluating devices in the Repair and Production Department.

Education and Experience:

• Bachelors degree in Engineering required.
• 5 years experience in a Quality Control or Quality Assurance 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, 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.

Thorough knowledge of applicable medical device regulations for electrical safety and EMI/EMC

Quality/Design Assurance Experience with Medical Capital Equipment.

Strong communication skills and ability to communicate effectively with technical and non-technical staff.

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