Chief Quality Officer

1 week ago

Biñan, Calabarzon, Philippines beBeeQuality Full time ₱600,000 - ₱1,200,000
Quality Assurance Expert

The role of Quality Assurance Expert is crucial in ensuring that all products meet the highest standards of quality.


Key responsibilities include:

  • Championing quality across the organisation and working towards fulfilling corporate mission objectives.
  • Maintaining and improving purpose-built Quality Management Systems (QMS) in accordance with ISO 13485 and ISO 9001 standards.
  • Ensuring overall compliance to standard operating procedures in line with QMS requirements.
  • Developing audit programs and plans, performing internal audits and coordinating external audits to ensure adherence to regulatory requirements.
  • Identifying and documenting opportunities for improvement in company processes and systems, working with subject matter experts to drive implementation and achieve desired outcomes.
  • Managing and processing CAPA-related activities, ensuring timely resolution of non-conformities and implementing corrective actions.
  • Providing expert advice on relevant standards and regulations for product development, 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 appropriate identification and records of product user needs, requirements verification and validation activities, and traceability throughout development.
  • Managing quality for medical device development 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 to ensure accuracy and precision.
  • Developing and conducting induction and training on QMS processes and policies, promoting QMS regulatory requirements to all staff.

Requirements

To be successful in this role, you will require:

  • A relevant qualification from a reputable education organisation.
  • 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

This role offers:

  • Remote work arrangement.
  • Permanent Full-Time or Contract employment options.

Job Function

Quality Assurance Expert.


Industries

Design Services.


About Us

Our team provides comprehensive design services to leading Australian and international companies across various industries.


We foster a collaborative environment, encouraging creative problem-solving and professional growth.


Join us in developing innovative solutions and delivering exceptional results.

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