Senior Manager, Quality Management Systems

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
• 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

Metrics & Continuous Improvement

• 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
• Cook up and coordinate all QMS Management Review activities

People Leadership

• 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.

Arthrex 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
• Tuition Reimbursement Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)
• Eligible for discretionary Long Term Incentive program