Senior Quality Assurance Professional

1 day ago

Quezon City, National Capital Region, Philippines beBeeQuality Full time ₱800,000 - ₱1,200,000
Job Title:

Quality Assurance Specialist

">About the Role:

We are seeking a highly skilled Quality Assurance Specialist to champion quality within our organization.

">Responsibilities:
  • Develop and implement a purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
  • Monitor and maintain overall compliance to standard operating procedures in line with the QMS.
  • Develop audit programs and plans, perform internal audits, and coordinate external audits.
  • Identify opportunities for improvement in company processes and systems and work with subject matter experts to drive implementation.
  • Manage and process CAPA related activities.
  • 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 in accordance with best practices.
  • Verify and validate product user needs, requirements, and records throughout development.
  • Manage quality for the development of medical devices according to regulation 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.

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