Quality Systems Specialist

About the role

The Quality Systems Specialist supports, maintains, and continuously improves the Quality Management System (QMS) for a medical device organization. This role ensures compliance with global regulations, especially ISO‑13485 and FDA 21 CFR 820, while driving process efficiency.

Key responsibilities

• Monitor and enhance QMS processes, including document control, training, change control, non‑conformance, and CAPA.
• Collaborate with Engineering, Manufacturing, and Quality teams to develop and sustain quality procedures.
• Prepare for and execute internal and external audits.
• Track and trend QMS non‑conformances and quality data, escalating issues as needed.
• Drive training programs and ensure regulatory compliance.
• Generate, analyze, and present quality metrics.
• Support CAPA investigations, effectiveness checks, and coaching of CAPA owners.
• Maintain electronic QMS documentation, approvals, and change management.
• Monitor new or revised external standards and regulatory requirements.

Required profile

• Bachelor’s degree in engineering, medical, science, or equivalent experience.
• Minimum 3 years of experience supporting quality systems in a regulated environment.
• Prior experience in the medical device industry, preferably with disposable and capital equipment.
• Strong leadership and interpersonal skills to work with cross‑functional teams.
• Fluent written and verbal English.

Required skills

• Knowledge of ISO‑13485 and FDA 21 CFR 820 requirements.
• Experience with CAPA processes and document control within an electronic QMS.
• Familiarity with audit preparation and execution.
• Lead Auditor certification (preferred) and Lean Six Sigma training (a plus).