Quality Assurance Expert

2 days ago

Cagayan de Oro, Northern Mindanao, Philippines beBeeQuality Full time ₱5,000,000 - ₱7,500,000

Quality Assurance Specialist


About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for championing quality within the organization.


Responsibilities
  • Championing quality within the organization, ensuring adherence to regulatory requirements and industry standards.
  • 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 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.
  • Advising on relevant standards and regulations for product developments, maintaining up-to-date libraries of applicable standards and regulations across global markets.
  • Facilitating company and product development risk management in accordance with best practices.
  • Facilitating 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 and standards.
  • 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.

Requirements
  • A relevant qualification from a reputable education organization.
  • 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.

Preferred Skills
  • ISO 17955 Lead Auditor certified.
  • Quality management experience in product design and development.

Work Arrangement

We provide workplace flexibility by allowing staff to work from home. Permanent and contractor roles are available.

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