Quality Assurance Specialist

1 week ago

Paranaque City, Calabarzon, Philippines beBeeQualityManager Full time ₱1,200,000 - ₱1,500,000
Job Summary

We are seeking a highly skilled and experienced Quality Manager to lead our quality management processes and team.

Main Responsibilities
  • Quality Champion: Promote quality within the organization, ensuring alignment with our corporate mission.
  • Quality System Maintenance: Monitor, maintain, and improve our purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.
  • Compliance and Audits: Ensure overall compliance to standard operating procedures in line with the QMS, develop audit programs, perform internal audits, and coordinate external audits.
  • Process Improvement: Identify opportunities for improvement in company processes and systems, work with subject matter experts to drive implementation, and manage CAPA related activities.
  • Regulatory Compliance: Identify and advise on relevant standards and regulations for product developments, maintain up-to-date libraries of applicable standards and regulations across global markets.
  • Risk Management: Facilitate company and product development risk management in accordance with best practices, including ISO 14971, IEC 60812, and ISO 31000.
  • Product Development: Manage 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.
  • Supplier Management: Select and evaluate suppliers, monitor quality agreements, and manage actions arising from goods inspection.
  • Training and Development: Develop and conduct induction and training on QMS processes and policies, and promote QMS regulatory requirements to all staff.
Requirements
  • Proven experience in quality management and leadership.
  • Knowledge of ISO 13485, ISO 9001, and other relevant standards and regulations.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
Benefits
  • Opportunity to work with a dynamic team.
  • Professional development and growth opportunities.
  • A competitive salary and benefits package.
About Us

We are a leading organization in the industry, committed to delivering high-quality products and services. We value our employees and strive to create a positive and supportive work environment.

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