Director, Quality Engineering — Strategy & Compliance

Advita Ortho, LLC; Gainesville (FL); On-site; USD 160,000 - 230,000; Full time

Job summary

Advita Ortho, LLC is seeking a Director, Quality Engineering to provide strategic leadership for quality strategy, regulatory compliance, product realization, and continuous improvement across the organization.

The role drives cross‑functional execution with Operations, R&D, Regulatory Affairs, and clinical teams to ensure safe, effective medical devices and compliant quality systems.

Qualifications

• 12+ years in quality, engineering, manufacturing, or regulatory roles
• Experience establishing and improving Quality System processes
• 8+ years in leadership of quality engineering or related functions
• In-depth knowledge of inspection strategy, GD&T, statistics, gage R&R, process validation
• Experience representing Quality during FDA inspections and audits

Responsibilities

• Define and oversee Quality Engineering strategy and compliance with regulatory requirements
• Lead cross-functional quality initiatives and audits
• Partner with Operations, R&D, Regulatory Affairs, Clinical, Supply Chain and executives
• Monitor metrics and risk indicators; support governance and decision making
• Represent Quality during internal and external audits and regulatory inspections

Skills

Executive communication

Leadership

Quality systems

GxP

Risk management

Education

Bachelor's degree in science

Master's degree preferred

Tools

GD&T

Gage R&R

Statistical methods

Process validation

Job description

Advita Ortho, LLC is seeking a Director, Quality Engineering to provide strategic leadership for quality strategy, regulatory compliance, product realization, and continuous improvement across the organization.

The role drives cross‑functional execution with Operations, R&D, Regulatory Affairs, and clinical teams to ensure safe, effective medical devices and compliant quality systems.