Sr. Director Quality Assurance

Department: Quality

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Chief QA/RA/CA officer

Description

The purpose of this role is to provide oversite and strategic direction to Advida’s Quality compliance and Strategy. 

Key Responsibilities

Leadership & Strategy

• 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.

Design Quality / New Product Development (NPD)

• 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, 

Sustaining Quality ·         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.
Operations Quality / Quality Control

• 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.

Regulatory & Compliance

• Ensure compliance with applicable regulations and standards (e.g., FDA QSR, ISO 13485), supporting audit readiness across design and manufacturing quality functions.

Cross‑Functional Collaboration

• 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.

Skills Knowledge and Expertise

Education:

• Bachelor’s Degree in a related field from an accredited institution required; Master’s Degree preferred

 Experience:

• Minimum 10 years’ experience in FDA/ISO medical devices quality management system standards required, orthopedic device industry preferred.
• Minimum 7 years’ experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations required.
• Supervisory or management experience required
• Project Management certification or equivalent experience preferred

Functional/Technical Knowledge, Skills and Abilities Required:

• RAPS certification preferred
• Working knowledge of windows-based office productivity tools including word processor and spreadsheet