Quality Assurance Specialist

1 month ago

Shanghai, Shanghai, China Hologic, Inc. Full time

Quality Assurance and Regulatory Compliance Specialist


Hologic, Inc. is seeking a highly motivated Quality Assurance and Regulatory Compliance Specialist to join our team.



Key Responsibilities:

  • Assist in establishing, implementing, and maintaining the company's quality management system to ensure compliance with relevant supply regulations and standards.
  • Responsible for communicating with 3PL, regarding the quality control of medical device during the warehousing and logistics processes, providing the manufacturing date, the expiration date, COC/COA, ensure they meet quality standards.
  • Monitor and record product quality issues, providing timely resolution and feedback.
  • Responsible for the update of work Instruction and quality agreements between Hologic and 3PL, auditing the quality assurance capabilities of 3PL.
  • Implement the Regulations for the Supervision and Administration of Medical Devices, maintain the company's business licenses, coordinate and monitor the implementation of Instructions for use and labels of medical devices.
  • Track updates to domestic and international medical device-related regulations and standards to ensure product and operational compliance.


Requirements:

  • Bachelor's degree or above.
  • Medical device related major.
  • More than five years of experience in medical device supply business QA.
  • Familiar with the relevant regulations of medical device supply business.
  • Strong communication and coordination skills.
  • Knowledge of Agile PLM software and Oracle is an advantage.
  • Excellent English speaking and writing skills.
  • Adapt to short-term travel.


If you are a motivated and detail-oriented professional with a passion for Quality Assurance and Regulatory Compliance, we encourage you to apply for this exciting opportunity.


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