We have a broad and high impact leadership opportunity for a dynamic individual to lead Quality Engineering Activities at our Santa Barbara facility. The Quality Engineering Supervisor will lead a seasoned team to further achieve world class quality manufacturing and superior new product development execution. This highly visible position shall have broad latitude to make a noticeable difference. If you have a bachelors engineering degree, seven years or more of proven quality engineering excellence in a Medical Electrical Equipment Device setting, apply now. We are located next to UC Santa Barbara, a premiere university in one of the most beautiful coastlines in the world.
Responsible for leading engineering team for manufacturing development of Class I and II medical devices in the achievement of company goals
Essential Duties and Responsibilities:
Supervises Quality Engineers and Quality Assurance Technicians assigned to manufacturing department work activities to provide timely and efficient flow of services and projects.
Participates in product design processes on high impact and complex designs through feasibility, initiation, planning, execution, and termination, adhering closely to project timeline.
Maintains a leading edge understanding of the quality processes required in manufacturing orthopedic devices and components in order to find new and novel opportunities to improve quality and reduce cost.
Assists in hiring and developing the manufacturing quality engineering team. Actively provides coaching and career development assistance to team members. Develops future leaders by effective selection and development activities.
Assists in assessing new manufacturing technologies and requirements for quality input.
Responsible for writing and/or assisting in the writing of validations, work instructions, and test reports.
Evaluates and develops improved quality techniques for the control of product activities.
Responsible for assisting in complaint investigations as related to product quality.
Develops and oversees the development of quality timelines for new product introduction activities in manufacturing.
Maintains applicable portions of design history file for assigned projects, adhering to Arthrex design control procedures.
Supports Manufacturing suppliers to provide quality and processing improvements.
Determines necessity of testing and inspection and initiates testing and inspection of assigned products.
Responsible as a designate for absent QC employees and the Document Control Specialist as directed by the QA Manager.
Reports progress and status of projects on a timely basis with emphasis on reporting results to the QA/QC Manager and Manufacturing Management.
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 of Science Degree in Engineering required.
Minimum 7 years Medical Quality related or Manufacturing Quality related experience
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Working knowledge of ISO and FDA quality requirements.
Manufacturing process knowledge.
Technical knowledge in development methodologies, design quality analysis, and project implementation.
Proficiency in assessing manufacturing quality requirements of new product ideas
Machine, Tools, and/or Equipment Skills:
PC, Auto Cad Station & applicable 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.