Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Sr Manager - Design Quality Assurance who works directly with the Quality & Design Engineering departments within Arthrex to provide strategic leadership of the corporate quality engineering team dedicated to design and development, manufacturing transfer, risk management and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals.  Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree in an Engineering field will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

This role is located in Naples Florida at our main Headquarters, it is not a remote role.

Essential Duties and Responsibilities:

1. Manages Managers, Supervisors, Quality Engineers and Quality Assurance Technicians assigned to design, risk management, and sustaining quality activities to provide compliant, timely, and efficient flow of services and design projects.
2. Maintains a leading-edge understanding of the quality processes required in design and post market performance in order to find new and novel opportunities to improve product quality, usability/human factors, and risk management while improving design efficiency and reducing time and cost to market.
3. Provides Design Assurance project oversight and management, including initiating and leading cross-functional teams dedicated to design assurance improvement and sound risk management processes.
4. Manages the overall Risk Management program and team oversite while ensuring compliance to ISO 14971 including risk in design and manufacturing.
5. Leads team as an SME in the development of compliant design inputs, user needs, and engineering requirements; ensuring needs can be validated and inputs / requirements can be verified.
6. Trains team members to develop design assurance plans for new products, research historical data (e.g., complaints, CAPA, etc.) and ensure quality objectives and risk management plans are defined and measurable for all design projects.
7. Provides technical assistance to Manufacturing, Quality and Operations groups throughout the early production builds and launch in support of design to manufacturing transfer and risk management.
8. Manage team and/or directly participates in all phases of product verification and validation.  Partners with Design Engineering in preparing protocols/test methodologies, developing sample sizes, and establishing acceptance criteria.  Reviews all test data, analysis, and final test reports.
9. Drives review of the effectiveness of the quality management system’ design and effectively identifies and implements enhancements as necessary to ensure maintenance of state-of-the-art processes and compliance to pertinent international standards and regulatory requirement, e.g., ISO 13485, 21 CFR 820, European MDR, rest of work regulations, etc., as well as pertinent reference standards such as ISO 14971 and IEC 62366;
10. Oversees timely and thorough investigation, root-cause analysis, completion, and effectiveness review of product design-related corrective and preventive actions (CAPA).
11. Leads strategic development of team organizational structure, hiring, and developing the quality engineering team and future leaders by actively coaching and providing career development assistance to team members.
12. Define and reports progress and status of projects and performance of processes through metric reviews on a timely basis with emphasis on reporting results to upper management.

Incidental Duties:

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 an Engineering field required, master’s degree preferred
• 8 years design / quality assurance experience required
• 5 years team management experience required
• Design Quality Assurance and Risk Management experience in medical device, aerospace, or other highly regulated industry required.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Working knowledge of design quality processes, risk management and quality requirements, e.g., design inputs, outputs, verification, validation, etc.
• Design to manufacturing process transfer knowledge.
• Technical knowledge in development methodologies, design quality analysis, and project implementation.

Machine, Tools, and/or Equipment Skills:

PC, Minitab, Solidworks (or similar), Microsoft Office, ERP (SAP, Agile, etc.) 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.