Job Description
Director of Quality Management
Location: Northern New Jersey
Industry: Medical Devices
X4 Life Sciences are partnered with a long‑standing organisation in the medical device sector, who seeking a Director of Quality. This position is well‑suited to someone who has operated at a senior Quality level, feels confident interacting with regulators, and prefers working in a stable environment with minimal bureaucracy.
Role Overview
The Director will oversee the entire Quality Management System and ensure it remains compliant, effective, and continuously improving. This includes day‑to‑day Quality operations, inspection readiness, and maintaining alignment with regulatory requirements. The role reports directly into senior leadership and includes managing a small, dedicated Quality team.
What You’ll Be Responsible For
- Oversee the full Quality function and ensure the QMS stays effective across QC, nonconformances, CAPA, supplier quality, complaints, audits, recalls, regulatory reporting, risk management, and continuous improvement.
- Maintain compliance with 21 CFR Part 820, ISO 13485, and all relevant standards.
- Serve as the Management Representative, updating leadership during Management Reviews.
- Lead FDA inspection activities and manage all related regulatory tasks, including recalls and adverse event reporting.
- Set and track Quality goals, KPIs, and performance metrics.
- Support customer and commercial Quality needs when required.
- Drive a strong Quality culture through communication, training, and cross‑functional collaboration.
- Lead investigations into nonconforming product or process issues and implement effective long‑term corrective actions.
- Approve CAPAs and verify sustained effectiveness.
What You’ll Need
- 12+ years of experience in the medical device industry.
- Strong background leading FDA‑ and ISO 13485‑compliant Quality Systems.
- Experience serving as a Management Representative or similar senior Quality authority.
- A track record of supporting FDA inspections and third‑party audits.
- Hands‑on experience with recalls, corrections/removals, and MDRs.
- Proven leadership experience managing people and teams.
- Background in mid‑sized or larger medical device environments with established Quality infrastructures.
- Bachelor’s or Master’s degree in Engineering, Science, Medical, or a related field
If you’re someone who thrives in a strong Quality‑focused environment, communicates well across teams and auditors, and you enjoy working with autonomy, reach out to [email protected].