Quality Assurance Director

1 week ago

Cavite City, Calabarzon, Philippines beBeeQuality Full time ₱900,000 - ₱1,234,567
Quality Management Specialist

The Quality Management Specialist is responsible for leading and supporting quality management processes and teams.

Key Responsibilities:

  1. Championing quality within the organisation to fulfill corporate missions.
  2. Monitoring, maintaining, and improving purpose-built Quality Management Systems in accordance with ISO 13485 and ISO 9001 standards.
  3. Ensuring overall compliance to standard operating procedures in line with QMS.
  4. Developing audit programs and plans, performing internal audits, and coordinating external audits.
  5. Identifying, planning, and documenting opportunities for improvement in company processes and systems and working with subject matter experts to drive implementation.
  6. Managing and processing CAPA-related activities.
  7. Identifying and advising on relevant standards and regulations for product developments, maintaining up-to-date libraries of applicable standards and regulations across global markets.
  8. Facilitating company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812, and ISO 31000.
  9. Facilitating appropriate identification and records of product user needs, requirements verification, and validation activities and traceability throughout development.
  10. Managing 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.
  11. Managing the calibration of test and measurement equipment.
  12. Selecting and evaluating suppliers, monitoring quality agreements, and managing actions arising from goods inspection.
  13. Developing and conducting induction and training on QMS processes and policies and promoting QMS regulatory requirements to all staff.

Requirements:

  • A relevant qualification from a reputable education organisation.
  • 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 a variety of 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.

Preferred Qualifications:

  • Quality management experience in product design and development.

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