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Please send us your CV by email, stating the position you are applying to: info@beyeonics.com

 

OPEN POSITIONS:

 

QA Manager

Job responsibilities:

  • Managing the company‚Äôs quality system in accordance with its established procedures and in compliance with ISO13485:2016 and relevant regulations (MDR, CFR, SOR, etc.)
  • Quality representative to management and leading management reviews
  • Guiding and instructing company management in application and implementation of the QMS procedures
  • Ownership of the documentation control process, including assignment of documents and QMS documentation maintenance
  • Ownership of supplier evaluation process
  • Ownership of QMS improvement processes (internal& external audits, CAPA)
  • Keeping up to date with regulatory advancements including relevant standards, guidance documents, regulations, etc.
  • Liasing with external parties regarding the QMS (i.e. NB, CA, EAR)

 

Required competencies:

  • At least 4 years experience as QA manager or QA specialist in a medical device company, preferably a startup engaged in design of an active, complex medical device (i.e. containing SW, HW,FW,Mech)
  • Experience in and ability to transition QMS from early design to full scale manufacturing including management of subcontractors and external production sites.
  • Academic education- preferably research-based MA
  • Well familiarized with core standards relevant to medical device industry (13485, 14971, 60601, 62304, 62366, 10993, etc.)
  • Very high level of written and spoken English
  • Ability to engage the company with quality as a core activity
  • Team player with ability to coordinate different interests and provide instruction for the benefit of quality
  • Organized, methodical, punctual, inquisitive, fast learner

To apply, please send your CV to: info@beyeonics.com