Requisition ID: 41093
Title: Engineer - QA - Design
Division: Arthrex, Inc. (US01)
Location: Naples, FL
Responsible for supporting the Quality Manager with all quality related support for the life cycle development of Class I, II and III medical devices, including new product development and maintenance of released products. This position requires leadership skills, the willingness and ability to mentor Quality Assurance Technicians.
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.
Leads multifunctional new product project teams in developing risk assessments, design inputs, test and inspection procedures, acceptance criteria and complaint analysis.
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.
Responsible for MRB activities for assigned products, timely resolution of nonconformities, 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 learning experience.
May supervise, assign, and coordinate the work of others on projects and assignments as appropriate.
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.
Supports manufacturing suppliers through audits, corrective and preventive actions, assistance in on-site resolution of quality and process related issues.
Reports progress and status of assigned projects on a timely basis with emphasis on reporting results to Upper 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’s degree required preferably in an Engineering or Science discipline.
At least three years’ experience in a Quality Control or Quality Assurance position required, preferably in a Medical Device Company.
Experience with Imaging & Resection devices preferred.
Experience in leading Risk Assessment, Failure Mode and Effects Analysis, and Fault Tree Analysis activities during Design & Development and Post Market Surveillance activities preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledge of ISO 14971, GD&T, design control requirements, testing and inspection equipment and techniques. Manufacturing process knowledge. Technical knowledge in development methodologies, design, and project implementation.
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.
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.