QMS Manager

15 hours ago

Pune, Maharashtra, India Cyient Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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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