Quality Assurance Director Role
We seek an experienced Senior Quality Assurance Professional to lead our Quality team and ensure compliance with FDA, ISO, and QSR standards.
Key Responsibilities:
* Lead and develop a small Quality team, providing coaching, support, and structure.
* Act as the site's management representative for FDA, ISO, and QSR compliance.
* Drive awareness of regulatory and quality system requirements across the organization.
* Oversee internal audits, non-conformance management, CAPA, and customer requirements.
* Lead quality improvement projects and contribute to Lean initiatives.
* Apply data-driven approaches (Minitab/statistical tools) to identify trends and improve product and process quality.
Essential Skills and Qualifications:
* 3+ years' experience in Quality Management within the medical device or FDA-regulated industry.
* 3–5 years of proven people management experience (small-team leadership essential).
* Strong knowledge of QSR and ISO standards; Lead Auditor certification preferred.
* Excellent communication, influencing, and team development skills.
* Solid problem-solving ability with a data-driven mindset.
This role is ideal for someone who enjoys balancing hands-on technical problem solving with people leadership, while playing a key part in maintaining and improving high-quality standards.