Senior Quality Systems Engineer & Regulatory Leader

Advita Ortho; Gainesville (FL); On-site; USD 110,000 - 150,000; Full time

Job summary

Advita Ortho in Gainesville, FL seeks a Senior Quality Systems Engineer to lead the development and stewardship of the company's Quality Management System, ensuring compliance with FDA regulations, ISO 13485, and MDR where applicable.

In this role you will direct CAPA, NC, and product removals, drive data analytics with PowerBI, and coordinate audits, training, and cross-functional initiatives to sustain product quality and patient safety.

Qualifications

• Bachelor's Degree in Engineering or related science; Master’s preferred.
• 6+ years in medical device quality/regulatory roles.
• Experience with eQMS tools (e.g., SmartSolve IQVIA, Cornerstone, Teamcenter).
• Experience in data management and reporting with PowerBI.
• ASQ certification or equivalent in Auditing for Medical Devices.
• Knowledge of FDA/ISO/MDR regulations.

Responsibilities

• Lead Quality Systems governance and ensure compliance with FDA/ISO standards.
• Oversee CAPA, audits, and NC/Removals processes.
• Manage QMS documentation and regulatory submissions.
• Provide data analytics and KPI reporting to leadership.
• Coach cross-functional teams in quality initiatives.
• Serve as SME during internal and external audits.

Skills

PowerBI

ASQ Auditing

eQMS Tools

Regulatory Knowledge

Education

Bachelor's degree in Engineering

Master's preferred

Tools

SmartSolve IQVIA

Cornerstone

Teamcenter

Job description

Advita Ortho in Gainesville, FL seeks a Senior Quality Systems Engineer to lead the development and stewardship of the company's Quality Management System, ensuring compliance with FDA regulations, ISO 13485, and MDR where applicable.

In this role you will direct CAPA, NC, and product removals, drive data analytics with PowerBI, and coordinate audits, training, and cross-functional initiatives to sustain product quality and patient safety.