Quality Assurance Manager - Tellico Village, United States - BlueHorizon Solutions

BlueHorizon Solutions
BlueHorizon Solutions
Verified Company
Tellico Village, United States

3 days ago

Michael Johnson

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Michael Johnson

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Description

We are looking for a highly qualified and motivated QA Manager to join our dynamic team in the medical technology industry at Tellico Village. In this position, you will play a crucial role in ensuring the highest quality standards, particularly in close collaboration with the laboratory.

Responsibilities:

  • Creation, review, archiving, and release of quality-related documents in accordance with applicable standards and laws.
  • Responsibility for conducting internal and external audits to ensure that processes and procedures meet quality standards.
  • Support of the Director of QA & RA in process responsibility for internal complaints, change management, CAPA, microbiological monitoring, and control of defective products.
  • Complaint management.
  • Handling of customer complaints, vigilance in collaboration with the QA/RA Director.
  • Evaluation and assessment of microbiological and biological results using your expertise to ensure accurate analysis and compliance with industry-specific standards.
  • Professional and disciplinary leadership responsibility for QS laboratory employees and the QA department.
  • Active participation and support in the change management process, contributing to continuous improvement of processes and procedures.
  • Review of validation and maintenance activities in collaboration with other departments.
  • Collaboration with other departments to qualify and monitor suppliers and service providers to ensure compliance with quality and regulatory expectations.

Qualifications:

  • Technical or
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