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Job description:

Append medical, a growing medical device start-up in the field of the structural heart is looking for a QA manager to establish a quality system and support the company RA activity.

 

Responsibilities:

  • Responsible for company’s Quality Compliance to ensure compliance with regulatory agencies and all applicable standards worldwide
  • Support the company RA activity
  • Establish and manage a QMS in compliance with FDA-QSR, MDR & ISO13485
  • Supporting R&D and manufacturing processes
  • Responsible for writing/guiding employees for writing all company procedures, specifications, instructions etc.
  • Periodic reports to Top management about Quality issues and analysis MRB, CAPA, ECOs, internal and external audits, product and process performance

 

Required Qualification:

  • 3+ years QA experience in the medical device field
  • A scientific degree
  • Experience in supporting regulatory activities in US and Europe
  • Experience in design control and manufacturing processes
  • Experience in supplier quality management
  • Excellent interpersonal skills
  • Well organized
  • High verbal and writing skills
  • Fluent in English.

 

Advantage

  • Experience with structural heart related devices
  • Experience with sterile devices and clean room

 

About Append Medical

Append Medical is a medical device start-up developing a system for reducing the risk of stroke in patients with non-valvular atrial fibrillation. Append’s system is designed to prevent blood clot leakage by achieving complete left atrium appendage (LAA) closure. Its unique design may allow it to mitigate device-related thromboembolism risk by leaving minimal foreign material at the closure site. The procedure itself is intended to be simple, fast and requiring less pre-procedure planning.

Please send relevant CVs to remo.almog@appendmedical.com

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