Sr. Director Quality Assurance
Full TimeJob Overview
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