Chief Quality Excellence Officer

2 days ago

Province of Palawan, Mimaropa, Philippines beBeeQuality Full time ₱6,000,000 - ₱8,000,000

Championing quality within an organization is a vital role that involves ensuring the fulfillment of corporate missions.


The Quality Manager will be responsible for monitoring, maintaining and improving the 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 is crucial to the success of this position.


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.
  • Ensuring the 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.
  • Calibrating 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.

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 communication skills.
  • Ability to work independently and as part of a team.

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

Location

Remote - Manila


Employment Type
  • Permanent Full-Time or Contract

Job Function
  • Quality Assurance

Industries
  • Design Services

About This Opportunity

This unique opportunity offers the chance to create innovative, human-centric products as part of one of Australia's leading product design teams.


Our multi-disciplinary product development consulting team is continuing to grow and provides comprehensive design services to leading Australian and international companies across various industries.


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


Work Arrangement

We offer workplace flexibility by allowing staff to work from home.

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