Advita Ortho · 10 hours ago
Sr. Director Quality Assurance
Gainesville, FL
Full-time
Onsite
Director/Executive
10+ years expAdvita Ortho is seeking a Senior Director of Quality Assurance to provide oversight and strategic direction for the company's quality compliance and strategy. This role involves developing and executing design assurance strategies, leading multi-disciplinary teams, and ensuring compliance with applicable regulations and standards.
Medical Device
Responsibilities
Develop and execute the Design Assurance strategy to support high‑quality product development and manufacturing outcomes
Partner with Quality Executive and cross‑functional leadership to drive continuous improvement and elevate organizational quality maturity
Lead, mentor, and develop multi‑disciplinary teams across Design Quality, Operations Quality, and Quality Inspection
Provide oversight for design controls and risk management activities across NPD programs
Ensure appropriate verification, validation, and design transfer processes are established and executed
Represent Quality in strategic portfolio planning and technical reviews
Support sustaining engineering teams to address product improvements, field performance issues, and product changes
Lead structured problem‑solving activities and support root cause investigations to ensure product reliability and regulatory compliance
Oversee inspection, in‑process control, and production quality requirements from incoming materials through final product release
Partner with Operations to ensure adherence to Quality System requirements
Identify and drive improvements in manufacturing quality metrics
Ensure compliance with applicable regulations and standards (e.g., FDA QSR, ISO 13485), supporting audit readiness across design and manufacturing quality functions
Facilitate strong partnerships with R&D, Operations, Supply Chain, Regulatory, and Clinical teams to ensure product quality objectives are achieved throughout the product lifecycle
Support executive‑level decision‑making related to product quality, risk, and compliance
Qualification
Required
Bachelor's Degree in a related field from an accredited institution
Minimum 10 years' experience in FDA/ISO medical devices quality management system standards
Minimum 7 years' experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations
Supervisory or management experience
Preferred
Master's Degree
orthopedic device industry
Project Management certification or equivalent experience
RAPS certification
Working knowledge of windows-based office productivity tools including word processor and spreadsheet
Company
Advita Ortho
Advita Ortho is a global medical device company committed to advancing patient lives through innovative orthopedic solutions.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase