Sr. Director Quality Assurance

Sr. Director Quality Assurance

Department: Quality

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Chief QA/RA/CA officer

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

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.

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