Senior Quality Professional

1 week ago

Pagadian, Zamboanga Peninsula, Philippines beBeeQuality Full time ₱56,000 - ₱87,000
Quality Assurance Role

The Quality Assurance Manager plays a pivotal role in ensuring the organisation's adherence to quality standards. This position involves championing quality throughout the company, monitoring and maintaining our purpose-built Quality Management System, and ensuring compliance with ISO 13485 and ISO 9001 standards.

  • Lead and support Quality Management processes and team by championing quality within the organisation, towards fulfilling our corporate mission.
  • Develop and implement audit programs and plans, perform internal audits, and co-ordinate external audits to ensure overall compliance to standard operating procedures in line with the QMS.
  • 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, including identifying and advising on relevant standards and regulation for product developments.
  • Facilitate company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812, and ISO 31000.
  • 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.

The following skills and experience are required for this role:

  • 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.
Key Responsibilities

This role is responsible for leading and supporting the Quality Management processes and team by championing quality within the organisation, towards fulfilling our corporate mission.

Requirements

The ideal candidate will have:

  • 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.

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