Quality Assurance Expert

1 day ago

General Santos, Soccsksargen, Philippines beBeeQuality Full time $80,000 - $120,000

**Job Overview**

We are seeking a highly skilled Quality Assurance Expert to lead and support our Quality Management processes and team.

Main Responsibilities:

  • Champion quality within the organization by implementing processes that align with our corporate mission.
  • Maintain and improve our Quality Management System (QMS) in accordance with ISO 13485 and ISO 9001 standards.
  • Ensure overall compliance to standard operating procedures in line with the QMS.
  • Develop and implement audit programs, perform internal audits, and coordinate external audits.
  • Identify opportunities for improvement in company processes and systems, and work with subject matter experts to drive implementation.
  • Manage CAPA-related activities and ensure timely resolution of non-conformities.
  • Stay up-to-date with relevant industry standards and regulations, including CE MDR, FDA, and TGA, and ensure compliance across global markets.
  • Facilitate risk management in accordance with best practices, including ISO 14971, IEC 60812, and ISO 31000.
  • Verify and validate product user needs and requirements, and ensure traceability throughout development.
  • Manage quality for the development of medical devices according to regulation and standards.
  • Select and evaluate suppliers, monitor quality agreements, and manage actions arising from goods inspection.

Requirements:

  • A 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 pertaining to product development.
  • Understanding of various production/manufacturing processes.
  • Excellent verbal and written communication skills.
  • Ability to work independently and as part of a team.

Benefits:

  • Opportunity to work on a diverse range of products and showcase expertise in quality assurance.
  • Comprehensive design services to leading Australian and international companies.
  • Flexible working arrangements, including remote work options.
  • Permanent and contractor roles available.

About Us:

We provide comprehensive design services to leading Australian and international companies. Our development team spans industrial and mechanical design, electronics, embedded, iOS, Android, Linux app, web servers, and more.

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