Chief Quality Officer

7 days ago


Tanauan, Calabarzon, Philippines beBeeQuality Full time ₱5,000,000 - ₱7,000,000
Quality Assurance Specialist Role

 

Job Overview

The Quality Assurance Specialist is responsible for championing quality within the organization, ensuring alignment with corporate mission and objectives.

Key Responsibilities:
  • Maintain and improve purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
  • Ensure overall compliance to standard operating procedures in line with QMS.
  • Develop and conduct internal audits, as well as coordinate external audits.
  • Identify opportunities for improvement in company processes and systems, working with subject matter experts to drive implementation.
  • Manage CAPA related activities and advise on relevant standards and regulations.
  • Facilitate risk management, including product development, using best practices such as ISO 14971, IEC 60812, and ISO 31000.
  • Manage quality for medical device development according to regulation (CE MDR, FDA, TGA) and standards (ISO 13485, IEC 60601, IEC 62304).
  • Oversee calibration of test and measurement equipment and select suppliers.
  • Develop and conduct induction training on QMS processes and policies.

 

Minimum Criteria:
  • 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.
  • Understanding of various production/manufacturing processes.
  • Experience in communicating with and evaluating local and offshore suppliers.
  • Excellent verbal and written English communication skills.


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