Vice President - Quality Assurance

Arthrex, a global leader in orthopedic medical device innovation, is seeking an accomplished executive to join our leadership team as Vice President, Quality Assurance at our Global Headquarters in Naples, Florida. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.

This highly visible role will lead and direct all global Quality Assurance activities across the design, development, manufacturing, purchasing, servicing, installation, and distribution of Arthrex medical devices. The Vice President will be responsible for ensuring product quality, maintaining regulatory compliance, driving operational excellence, and accelerating speed to market across our global organization.

As a key member of the leadership team, you will:

• Lead and direct all global Quality Assurance functions - including Design QA, Risk Management, Operations QA/QC, Supplier QA, Sterilization Sciences/Biological Safety, Quality Systems/Compliance, CAPA, Document Control, Complaint Handling at all sites (as applicable) within the scope of the Arthrex global Quality Management System (QMS).
• Support the continuous assessment and global alignment of the QMS with additional Arthrex sites, subsidiaries, and acquisitions as appropriate.
• Maintain the global Quality Management System to ensure compliance with FDA QMSR (Quality Management System Regulation), Medical Device Single Audit Program (MDSAP), ISO 13485, European Medical Device Regulation, and all other applicable worldwide regulatory requirements.
• Global QMS Management Representative for MDSAP and ISO 13485.
• Designated Person Responsible for Regulatory Compliance, in accordance with the requirements for the EU Medical Device Regulations 2017/745, specifically, ensuring:
• conformity of the device to the Quality Management System; and compliance with the vigilance reporting activities specified in the Article 87-91 of the EU MDR
• Coordinate and manage external regulatory compliance QMS inspections and assessments.
• Coordinate and manage periodic Executive QMS Management Review and all related metrics.
• Partner with Design Engineering, Product Management, Operations etc. to implement product/process improvements, and drive operational efficiency and speed to market.
• Ensure compliance within functional area and support the compliance objectives of the organization as a whole.
• Up to 25% domestic and international travel.

Education and Experience:

• Bachelor’s Degree required, preferably in Engineering or Science.
• Minimum of 15 years of experience in the medical device industry (preferably in orthopedics) with an extensive focus on Quality Assurance experience related to medical device design and manufacturing.
• A minimum of 15 years of experience in a leadership role.
• Orthopedic industry experience preferred.

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

In-depth working knowledge of FDA QMSR (Quality Management System Regulation), MDSAP, ISO 13485, EU Medical Device Regulation requirements, and extensive experience interacting with regulatory agencies and notified bodies. Ability to lead, direct and develop diverse high performing teams, and collaborate effectively with other groups to achieve company objectives.

Machine, Tools, and/or Equipment

Skills:

PC, MS Office, SAP, automated Quality System software such as Documentum and Pilgrim Smart Solve.

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…