Senior Manager, Quality Systems
Arthrex - Naples, FL
Hiring: Senior Manager, Quality Systems Company: Arthrex Location: Naples, FL Job Posted Time: 2026-09-10 15:15:19 Employment Type: On-site Target Skills & Keywords : Change Management, Microsoft Excel, Microsoft PowerPoint, Risk Management, SAP About the job Experience: •15 years related experience required in a medical device or similar regulated environment •8 years of quality leadership experience required •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 Required Skills: •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 •Provides Oversight Of Critical Quality System Elements •CAPA (Corrective and Preventive Actions) •Nonconformance (NCR) management •Document Management / Change control Qualifications: •Eligible for discretionary Long Term Incentive program •Bachelor’s degree required, preferably in an Engineering or Science discipline Compensation: •Medical, Dental and Vision Insurance Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!