Not specified; annual bonus available; matching 40...
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Fda 21 cfr part 820 compliance
Iso 13485 regulatory standards
Capa and nonconformance management
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Arthrex Inc. is seeking a Senior Manager for Quality Management Systems at their Naples, FL headquarters. The role focuses on leading the quality management system to ensure compliance with global regulatory standards while fostering a culture of continuous improvement.
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Job Summary
The Senior Manager will lead the end-to-end Quality Management System to ensure compliance with FDA and ISO 13485 regulations.
This role drives continuous improvement initiatives across core processes such as CAPA, change management, and document control.
Arthrex offers a comprehensive benefits package including matching 401(k), paid parental leave, and tuition reimbursement.
Matching Summary
Match Score: 75
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Arthrex Inc. is seeking a Senior Manager for Quality Management Systems at their Naples, FL headquarters. The role focuses on leading the quality management system to ensure compliance with global regulatory standards while fostering a culture of continuous improvement.
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Salary
Not specified; Annual Bonus available; Matching 401(k) and Long Term Incentive program eligible
Skills & Requirements
Must-have
FDA 21 CFR Part 820 compliance
ISO 13485 regulatory standards
CAPA and nonconformance management
Internal audit program leadership
Regulatory inspection readiness
Nice-to-have
Cross-functional collaboration skills
Strategic quality system thinking
Data analytics for quality trends
Continuous improvement culture
Multi-site global experience
Key Requirements
Bachelor's degree in Engineering or Science
15 years related experience in medical device industry
8 years of quality leadership experience required
Experience supporting FDA or notified body inspections