Work from Office
Full Time
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.
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.
Cyient
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