Senior Quality Systems Leader | Global Medical Devices

Arthrex GmbH; Naples (FL); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Flexible Spending Account (FSA)

Tuition Reimbursement Program

Annual Bonus

Paid Time Off

Job summary

Arthrex GmbH is seeking a Senior Manager, Quality Management Systems in Naples, Florida, to lead and continuously improve the Quality Management System (QMS) ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and other standards.

This role includes driving quality system effectiveness across processes such as CAPA and training. The candidate should have a Bachelor's degree, 15 years' experience in a regulated environment, and leadership in global quality systems.

Qualifications

• 15 years related experience in a medical device or similar regulated environment.
• 8 years of quality leadership experience required.
• Experience with global/multi-site quality systems.

Responsibilities

• Lead and oversee the end-to-end QMS ensuring compliance with FDA and ISO 13485.
• Establish and drive quality strategy and system performance metrics.
• Implement risk-based approaches to quality system monitoring.

Skills

Leadership skills

Regulatory compliance knowledge

Strategic thinking

Cross-functional influence

Problem-solving capabilities

Education

Bachelor's degree in Engineering or Science

Tools

Excel

PowerPoint

SAP

Job description

Arthrex GmbH is seeking a Senior Manager, Quality Management Systems in Naples, Florida, to lead and continuously improve the Quality Management System (QMS) ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and other standards.

This role includes driving quality system effectiveness across processes such as CAPA and training. The candidate should have a Bachelor's degree, 15 years' experience in a regulated environment, and leadership in global quality systems.