QMS Manager
7 days ago
Roles & Responsibilities
- Manage and maintain the QMS, ensuring compliance with global medical device regulations.
- Lead internal and external audits; ensure timely closure of findings.
- Oversee document control, CAPA, training, and change management processes.
- Monitor quality metrics and drive continuous improvement initiatives.
- Support regulatory inspections, product registrations, and management reviews.
- Collaborate with cross-functional teams to ensure quality integration in all processes.
- Train and mentor team members on QMS requirements and best practices.
Qualifications
- Bachelor's/Master's in Engineering, Mechanical or related field.
- 7+ years' experience in Quality Assurance, with 3+ years in a managerial/QMS role.
- Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820, and EU MDR.
- Experience with audits (Notified Body/FDA) and QMS implementation.
- Excellent leadership, communication, and problem-solving skills.
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