Senior Quality Assurance Specialist

1 day ago

Bacoor, Calabarzon, Philippines beBeeQuality Full time ₱400,000 - ₱800,000
Job Overview

The role of Quality Manager is a pivotal position within the organization, responsible for leading and supporting the Quality Management processes and team.

Key Responsibilities
  1. Champion quality within the organization, ensuring it aligns with our corporate mission.
  2. Maintain our purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
  3. Ensure overall compliance to standard operating procedures in line with the QMS.
  4. Develop audit programs and plans, perform internal audits, and co-coordinate external audits.
  5. Identify opportunities for improvement in company processes and systems, work with subject matter experts to drive implementation, and manage CAPA related activities.
  6. Advise on relevant standards and regulations for product developments, maintain up-to-date libraries of applicable standards and regulations across global markets.
  7. Facilitate company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812, and ISO 31000.
  8. 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.
  9. Calibrate test and measurement equipment, select and evaluate suppliers, monitor quality agreements, and manage actions arising from goods inspection.
  10. Develop and conduct induction and training on QMS processes and policies, promoting QMS regulatory requirements to all staff.
Requirements
  • 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.
  • Excellent verbal and written English communication skills.
  • Ability to work independently and as part of a team.

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