Senior Quality Assurance Professional

3 days ago

Antipolo City, Calabarzon, Philippines beBeeProduct Full time ₱3,000,000 - ₱4,500,000

Quality Assurance Specialist

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This position involves championing quality within the organisation, to ensure all processes and systems are functioning as per our corporate mission.


The role requires monitoring, maintaining and improving our Quality Management System in line with ISO 13485 and ISO 9001 standards.


  • We are seeking a candidate with in-depth knowledge of ISO 13485 and ISO 9001, as well as regulatory requirements pertaining to product development.
  • A relevant qualification from a reputable education organisation is also required.
  • At least 5 years' experience in quality management or a similar role is necessary.

Key Responsibilities:
  • 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.
  • Facilitating company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812 and ISO 31000.
  • Facilitating appropriate identification and records of product user needs, 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.
  • 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.

Benefits:
  • Permanent Full-Time or Contract options available.
  • Remote work arrangement.
  • Opportunity to work with a leading product design team.

About Us:

We provide comprehensive design services to leading companies across various industries.


Our team spans industrial and mechanical design, electronics, embedded, iOS, Android, Linux app, web servers and more.


We offer a full turnkey service and a unique opportunity for creative and passionate professionals to continue to develop their skills.


We promote a culture of innovation and human-centric product development.


We believe in providing our employees with a positive work environment and opportunities for growth and development.


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