Lead Quality Expert

1 week ago

Biñan, Calabarzon, Philippines beBeeQuality Full time ₱900,000 - ₱1,200,000
Quality Assurance Specialist

As a Quality Assurance Specialist, you will be responsible for leading and supporting the company's quality management processes and team.

  • Championing quality within the organisation by ensuring compliance with corporate mission objectives.
  • Maintaining and improving the purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
  • Ensuring overall adherence to standard operating procedures in line with the QMS.
  • Developing audit programs and plans, performing internal audits and coordinating external audits.
  • Identifying opportunities for improvement in company processes and systems and working with subject matter experts to drive implementation.
  • Managing and processing CAPA related activities.
  • Providing guidance on relevant standards and regulations for product developments and maintaining up-to-date libraries of applicable standards and regulations across global markets.
  • Facilitating risk management in accordance with best practices, including ISO 14971, IEC 60812 and ISO 31000.
  • Ensuring 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.
  • 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.

Requirements:

  • A relevant qualification from a reputable education institution.
  • 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 various 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.

Benefits:

  • We provide comprehensive design services to leading companies across various industries.
  • We offer a full turn-key service for our customers and a unique opportunity for creative professionals to develop their skills.
  • We provide workplace flexibility by allowing staff to work from home.

About Us:

We are a multi-disciplinary product development consulting team committed to delivering innovative products and solutions to our clients. Our team spans industrial and mechanical design, electronics, embedded, iOS, Android, Linux app, web servers and more.

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