Executive / senior industry position
Responsible for supporting the Arthrex organization with all quality and compliance related support for the life cycle development of Class I, II and III medical devices, including new product development and maintenance of released products. Recognized as a technical leader and resource.
Essential Duties and Responsibilities:
Leads Q.A. Engineering efforts and is a key technical contributor during New Product Development. Actively participates with multifunctional new product project teams in developing risk assessments, design inputs, test and inspection procedures, acceptance criteria and complaint analysis.
A key contributor in design for manufacture, test and successful design transfer to ensure that new products shall meet specification/requirements.
May supervise and/or direct other members of the quality staff to assist them in their assignments and provide them with learning experience.
Provides expert consultation in one or more areas of quality control, quality systems, design assurance, and design & development activities in order to find new and novel opportunities to improve quality and reduce costs.
Recommends alterations in product to improve quality of products and/or procedures.
Supports/reviews design history file deliverables for assigned projects, completion and adherence to design control procedures.
Reviews and analyzes Arthrex’s protocols, validations, reports, design and verification tests to determine that Company standards are met. Performs Failure Modes, Effect and Criticality Analysis (Design or Process FMEAs/ FMECAs) with project team members.
Supports manufacturing suppliers to provide quality and processing improvements. Assists in resolution of quality and process related issues.
Complies with U.S. Food and Drug Administration (FDA) regulations, ISO13485, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Leads compliance efforts for electrical safety, environmental and emissions as required by various national and international regulations.
Resolves and/or facilitates the resolution of problems including identifying causes to prevent reoccurrence.
Performs related functions and responsibilities, on occasion, as assigned.
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 in an Engineering or Engineering Technology discipline. MS preferred.
Minimum 15 years of relevant experience in a Quality or Design Assurance position in a Medical Device or other highly regulated industry.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Expert understanding of quality control practices, standards and principles
Expert understanding of statistical process controls, root cause analysis and supplier controls.
Expert understanding of Quality Management Systems and Risk Assessment/Hazard Analysis.
Quality/Design Assurance Experience with Medical Capital Equipment.
Demonstratable experience in Quality Design Practices for Manufacturability.
Working knowledge of electrical safety standards.
Working Knowledge and historical perspective of orthopedic surgery principles, theories, and products.
Working knowledge of anatomy from an orthopedic standpoint.
Expert understanding of FDA and ISO guidelines for medical devices required.
Strong communication skills and accountability to project deliverable timing.
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.