Product Safety Compliance Specialist

2 weeks ago

Imus, Calabarzon, Philippines beBeeQuality Full time ₱1,023,234 - ₱1,274,567
Quality Management Expert

Your key responsibilities in leading and supporting Quality Management processes and team are:

  • Championing quality within the organisation, towards fulfilling our corporate mission.
  • 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 opportunities for improvement in company processes and systems and working with subject matter experts to drive implementation.
  • Managing CAPA related activities.
  • Facilitating company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812 and ISO 31000.
  • Facilitating identification and records of product user needs and requirements verification and validation activities and traceability throughout development.
  • Managing 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.
  • Managing the calibration of test and measurement equipment.
  • Selecting and evaluating suppliers, monitoring quality agreements, and managing actions arising from goods inspection.
  • Developing and conducting induction and training on QMS processes and policies, and promoting QMS regulatory requirements to all staff.

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.

The following skills and experience are preferred for this role:

  • Quality management experience in product design and development.

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