QA Engineer

Company Background

Enopace Biomedical has developed an innovative, permanently implanted, RF operated active implantable aortic neuromodulation System for the treatment of congestive heart failure patients. The System is currently in the clinical study phase.

 

 Job Summary

    1. Perform Quality Management System (QMS) activities as part of the RA/QA Department.
    2. Support the Operations & Manufacturing Department in performing Engineering and Supply Chain activities.
    3. The position reports to the VP RA/QA.

Duties & Essential job Functions

  1. RA/QA Department
    1. Material Review Board (MRB)
    2. Verification and validation (V&V) testing activities including preparation of protocols and reports and test execution
    3. Approved supplier’s process
    4. Lot release
    5. Risk management
    6. Corrective and Preventive Action (CAPA) including root cause analysis
    7. Design History File (DHF) and Device Master Record (DMR)
    8. Complaint handling
    9. Internal and external audits
    10. QMS SOPs
  2. Operations & Manufacturing Department
    1. Document control
    2. Change control (ECO)
    3. Incoming inspection
    4. Final QC

Experience/Skills Required

    1. Practical engineering degree or equivalent technical certification, or
    2. Bachelor’s degree in engineering or scientific discipline – an advantage
    3. At least 3-5 years work experience in a medical device QA role working under an ISO 13485 certified QMS
    4. Excellent communication, organizational and recordkeeping skills
    5. Strong English technical writing skills
    6. Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
    7. Must be able to work in multi-disciplinary teams
    8. Experience with clean room manufacturing – an advantage
    9. Experience with V&V testing – an advantage
    10. Experience with active implants – an advantage

we invite you to send an application to
careers@enopace.com

Apply

Contact Us


    *Name

    *Email


    Enopace Biomedical Ltd.

    5 Tarshish St.
    Business Park, North
    P.O.B 3546 Caesarea 3079821, Israel

    Skip to content