Quality Manager

About the role

Cirtec Medical is seeking an experienced Quality Manager to lead its Quality Management System (QMS) and ensure compliance with regulatory standards for Class II and III medical devices. The role will oversee quality personnel, drive continuous improvement, and act as the Management Representative for the QMS.

Key responsibilities

• Maintain and enforce compliance with the QMS, ISO 13485, and FDA regulations.
• Lead Management Review meetings, report system performance, and identify improvement actions.
• Oversee complaint analysis, CAPA processes, and metric tracking.
• Manage Quality Control staff for incoming, in‑process, final inspection, and product release activities.
• Create and maintain site‑specific Quality Plans and support design control documentation (DHF).
• Provide leadership, coaching, and mentorship to Quality and cross‑functional teams.
• Collaborate with corporate quality leaders to sustain site registrations and cGMP best practices.

Required profile

• Proven experience leading quality functions in a regulated medical device environment.
• Strong understanding of ISO 13485, FDA 21 CFR Part 820, and cGMP requirements.
• Ability to drive cross‑functional collaboration and mentor teams.
• Excellent analytical and problem‑solving skills for CAPA and complaint handling.

Required skills

• ISO 13485 compliance
• FDA regulatory knowledge
• cGMP implementation
• CAPA management
• Design History File (DHF) control
• Quality Management System (QMS) administration
• Quality Control inspection processes