Senior Quality Systems Specialist

1 week ago

Hagonoy, Central Luzon, Philippines beBeeQuality Full time ₱60,000 - ₱80,000

Job Summary:

This role involves leading and supporting the Quality Management processes and team.

  • Championing quality within the organisation, towards fulfilling our corporate mission.
  • Monitoring, maintaining and improving our purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
  • Ensuring overall compliance to standard operating procedures in line with the QMS.
  • Developing audit programs and plans, performing internal audits and co-ordinating external audits.
  • Identifying, planning and documenting opportunities for improvement in company processes and systems and working with subject matter experts to drive implementation.
  • Managing and processing CAPA related activities.
  • Identifying and advising on relevant standards and regulation for product developments, maintaining up to date libraries of applicable standards and regulation across global markets.
  • Facilitating company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812 and ISO 31000.
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 Skills:
  • Quality management experience in product design and development.

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