Requisition ID : 61076 Title: Engineer Sr. I - QA ACT Division: Arthrex California Inc (US03) Location: Santa Barbara, CA Salary Range:Salary Minimum: $109,250.00 Salary Maximum: $156,687.50
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 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 Bachelor's 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 Better™.
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:
Bachelor's 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 GD&T, 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.
Project management skills preferred.
Recognized process improvement (i.e.: Lean, Six Sigma) and problem-solving (i.e.: RCA, DMAIC, 5 Whys) training preferred.
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, and RoHs Directives.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), SAP or similar inventory software.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Mathematical Skills
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills:
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management.Ability to write and record data and information as required by procedures.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.
Vision Requirements:
Visual acuity is necessary to do the job safely and effectively.
Specific vision abilities required by this job include close vision.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
