Director Operational Risk Management Jobs in Naples, FL

Title: Senior Manager, Quality Management Systems

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 Management Systems for our global headquarters in Naples, Florida. The Senior Manager, Quality Management 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.

Duties and Responsibilities:

Quality System Leadership

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.

Core QMS Process Ownership

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.

Audit & Inspection Readiness

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.

Compliance & Risk Management

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.

Education and Experience:

• 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

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

• 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

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), PowerPoint, SAP or similar business software.

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 perform the job based upon job requirements.

Language and Communication Skills:

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.

Benefits:

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Time Off
• Employee Assistance Provider (EAP)
• Eligible for discretionary Long Term Incentive program

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.