Senior Quality Assurance Manager

2 weeks ago

Porac, Philippines beBeeQuality Full time ₱1,500,000 - ₱1,700,000

Job Summary

We are seeking a seasoned Quality Assurance Specialist to champion quality within our organization, driving excellence in all aspects of product development and delivery.

Main Responsibilities

  • Develop and maintain our Quality Management System (QMS) according to ISO 13485 and ISO 9001 standards, ensuring seamless compliance and continuous improvement.
  • Lead internal audits, coordinate external audits, and identify opportunities for process enhancements, collaborating with experts to drive implementation.
  • Manage corrective actions, advise on regulatory requirements, and facilitate risk management and identification of product user needs.
  • Ensure quality compliance for medical device development, adhering to CE MDR, FDA, and TGA standards, as well as ISO 13485 and IEC 62304.
  • Select and evaluate suppliers, monitor quality agreements, and manage actions arising from goods inspection.

Requirements

  • Relevant qualification from a reputable education institution.
  • At least 5 years' experience in quality assurance 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.
  • Excellent verbal and written English communication skills.

PREFERRED SKILLS

  • ISO 17955 Lead Auditor certification.
  • Quality assurance experience in product design and development.

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