Senior Manager, Quality Management Systems

Arthrex•Pelican Bay, FL

6d•Onsite

About The Position

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 a Senior Manager, Quality Systems for our global headquarters in Naples, Florida. The Senior Manager, Quality Systems is responsible for leading, maintaining, and continuously improving the Arthrex Quality Management System (QMS) to ensure compliance with global regulatory requirements including FDA 21 CFR Part 820, ISO 13485, and other applicable standards. This role drives quality system effectiveness across core processes such as CAPA, change management, audits, document control, and training, while supporting inspection readiness and enabling business growth. This position requires a strategic leader who can balance compliance with operational efficiency, foster cross-functional collaboration, and elevate quality systems as a proactive enabler of organizational excellence. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

Bachelor’s degree required, preferably in an Engineering or Science discipline
15 years related experience required in a medical device or similar regulated environment
8 years of quality leadership experience required
Experience with global/multi-site quality systems
Experience supporting FDA or notified body inspections
Strong working knowledge of FDA QSMR, ISO 13485 and applicable international regulations.
Proven experience leading audits and regulatory inspections
Strong leadership and people development skills
Ability to influence cross-functional stakeholders at all levels
Strategic thinker with strong execution and problem-solving capabilities
Experience driving system improvements and transformation initiatives
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), PowerPoint, SAP or similar business software.
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.
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
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.

Responsibilities

Lead and oversee the end-to-end QMS, ensuring compliance with FDA, ISO 13485, and global regulatory requirements
Establish and drive quality strategy, governance, and system performance metrics
Ensure alignment and scalability of quality systems across sites and functions
Provides oversight of critical quality system elements: CAPA (Corrective and Preventive Actions), Nonconformance (NCR) management, Document Management / Change control, Document and record control, Training and competency systems
Drive continuous improvement initiatives to enhance system effectiveness and reduce risk
Lead and develop risk-based internal audit program and schedules
Ensure ongoing inspection readiness and lead FDA, notified body, and other regulatory inspections
Partner with site leadership to address audit findings and drive sustainable corrective actions
Implement risk-based approaches to quality system monitoring and decision-making
Ensure timely identification, escalation, and resolution of compliance gaps
Monitor regulatory changes and drive system updates accordingly
Establish and monitor KPIs for QMS effectiveness (e.g., CAPA cycle time, audit trends, training compliance)
Leverage data analytics to identify trends, systemic issues, and improvement opportunities
Coordinate and support all QMS Management Review activities.
Lead, develop, and mentor a team of quality professionals
Build a culture of ownership, accountability, and continuous improvement
Drive capability development in auditing, compliance, and quality system processes