Quality Specialist

20 hours ago

Waltham, Massachusetts, United States Paragonix Technologies Full time

Description Introduction

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screening to the transplant community.

Position Overview: The Quality Specialist will play a crucial role in ensuring all documentation meets expected standards for quality for the organization, including ensuring compliance to regulatory requirements. This role is responsible for the organization, management, and maintenance of all document and records belonging to the Quality Management System.

Primary responsibilities/authority will include:

  • Change Order Management – this role will have Document Control responsibilities, and all routed records in the QMS will need a Document Control approval.
  • Training Assignments – Ensuring all updates with required training are appropriately assigned and completed
  • DHR Review and lot release
  • Support internal and external audits – Provide necessary documents for audits and ensure compliance
  • Must have strong written and verbal communication skills
  • Proficient with Document Management software systems

Required Qualifications:

  • 0-3 years experience working in a regulated industry (FDA, MDR, and ISO 13485 background preferred) as a document control specialist.
  • Bachelor's degree preferred

Salary Range is $65,000-$80,000 based on experience

Description Conclusion

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