Chief Quality Assurance Officer

1 week ago

Pasig, National Capital Region, Philippines beBeeQuality Full time ₱5,000,000 - ₱8,500,000
Job Description

Our team is looking for a Quality Manager to lead and support our Quality Management processes and team. As a key member of our organization, you will be responsible for championing quality within the company and ensuring overall compliance to standard operating procedures.

You will monitor, maintain and improve our purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards. This includes developing audit programs and plans, performing internal audits and coordinating external audits.

Additionally, you will identify, plan and document opportunities for improvement in company processes and systems and work with subject matter experts to drive implementation.

Another key responsibility is managing and processing CAPA related activities.

Furthermore, you will identify and advise 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, is also part of your role.

Moreover, you will facilitate appropriate identification and records of product user needs, requirements verification and validation activities and traceability throughout development.

The final aspect of this role is 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.

Required Skills and Qualifications

We are looking for a candidate with the following skills and qualifications:

  • 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 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.
Benefits

As a Quality Manager, you will have the opportunity to work on a diverse range of products and showcase your excellence in design.

Our company provides comprehensive design services to leading Australian and international companies for a wide range of industries.

Others

Our workplace flexibility allows staff to work from home.

Permanent and contractor roles are available.

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