Senior Manager of Quality Assurance

7 days ago

Dumaguete, Central Visayas, Philippines beBeeQuality Full time ₱6,000 - ₱7,000

As a Quality Director, you will lead and support quality management processes and teams. Your responsibilities will include championing quality within the organization to fulfill its corporate mission.

  • Monitor, maintain, and improve the purpose-built Quality Management System in line with ISO 13485 and ISO 9001 standards.
  • Ensure overall compliance to standard operating procedures according to the QMS.
  • Develop audit programs and plans, perform internal audits, and coordinate external audits.
  • Identify, plan, and document opportunities for improvement in company processes and systems and work with subject matter experts to drive implementation.
  • Manage and process CAPA related activities.
  • Identify and advise on relevant standards and regulations for product developments and maintain up-to-date libraries of applicable standards and regulations across global markets.
  • Facilitate company and product development risk management according to best practices, including ISO 14971, IEC 60812, and ISO 31000.
  • Facilitate appropriate identification and records of product user needs, requirements verification, and validation activities and traceability throughout development.
  • Manage quality for the development of medical devices according to regulations such as CE MDR, FDA, and TGA and standards including ISO 13485, IEC 60601, and IEC 62304.
  • Manage the calibration of test and measurement equipment.
  • Select and evaluate suppliers, monitor quality agreements, and manage actions arising from goods inspection.
  • Develop and conduct induction and training on QMS processes and policies and promote QMS regulatory requirements to all staff.

The following skills and experience are required:

  • A relevant qualification from a reputable education organization.
  • At least 5 years' experience in quality management or a similar role.
  • In-depth knowledge of ISO 13485 and ISO 9001, as well as regulatory requirements pertaining to product development.
  • Understanding of various production/manufacturing processes.
  • Experience in communicating with and evaluating local and offshore suppliers.
  • Excellent verbal and written English communication skills.
  • Ability to work independently and as part of a team.

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