Quality Assurance Professional

2 days ago

San Juan, National Capital Region, Philippines beBeeQualityAssurance Full time ₱60,000 - ₱75,000
Quality Assurance Expert

We are seeking a seasoned Quality Assurance Expert to champion quality initiatives and lead the development of our Quality Management System.

Key Responsibilities:

  • Establishing and maintaining a robust Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
  • Ensuring overall compliance to standard operating procedures within the QMS framework.
  • Developing audit programs, performing internal audits, and coordinating external audits to ensure regulatory adherence.
  • Identifying and implementing opportunities for improvement in company processes and systems through collaboration with subject matter experts.
  • Managing CAPA related activities and ensuring effective root cause analysis and corrective actions.
  • Staying up-to-date with relevant industry standards, regulations, and best practices, including ISO 14971, IEC 60812, and ISO 31000.
  • Facilitating risk management throughout product development, from initial concept to market release.
  • Ensuring quality requirements are met and documented, with thorough validation and verification of product user needs and requirements.
  • Leading quality assurance efforts for medical device development, adhering to regulatory requirements such as CE MDR, FDA, and TGA.
  • Maintaining calibration of test and measurement equipment and selecting suppliers based on quality agreements and performance metrics.
  • Developing and delivering training programs on QMS policies and procedures, promoting quality awareness among staff members.

Required Skills and Experience:

  • A degree in a relevant field from an accredited institution.
  • At least 5 years of experience in quality assurance or a related role.
  • Extensive knowledge of ISO 13485, ISO 9001, and other relevant regulatory requirements.
  • Understanding of various production and manufacturing processes.
  • Proven ability to communicate effectively with suppliers and stakeholders.
  • Excellent written and verbal communication skills in English.
  • Ability to work independently and collaboratively as part of a team.

Preferred Skills and Experience:

  • Experience in quality assurance within product design and development.

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