QA Engineer

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.lime-cube.com

Apply

Contact Us

    *Email


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    Enopace Biomedical Ltd.

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

    (+972) 4 - 6378827
    (+972) 4 - 6378533
    info@enopace.lime-cube.com
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    CEO Profile Image

    David Handler

    President and CEO

    David M. Handler joined as President and Chief Executive Officer of Enopace Biomedical in March of 2023. Prior to joining Enopace, Mr. Handler served as Global Vice President and General Manager of Philips Healthcare’s Cardiology Ultrasound Business where he achieved significant annual growth in revenue, market share and profitability. He also led important M & A activities including the acquisition of TOMTEC imaging systems and development, FDA clearance and commercialization of breakthrough AI applications for Echo analysis. Previously, he was President and CEO of Corindus Vascular Robotics where he led the development of the CorPath robotic system, from prototype through IDE clinical trial, FDA clearance and commercialization with more than 100 employees. The CorPath system was the first cath lab robot ever used for coronary stenting procedures. He also drove Corindus’ development from a venture backed private company with five employees to a publicly traded company and IPO raising more than $90m and more than 100 employees. Corindus was eventually acquired by Siemens Healthcare for $1.1B after Mr. Handler had departed.

    Prior to Corindus he held General Manager positions at General Electric from October 1998 until September 2008. Mr. Handler has over 30 years of successful service in sales, product management, marketing and leadership roles in the medical device, medical imaging and informatics and plastics industries. Mr. Handler earned a B.A. in Economics from Union College in Schenectady, New York and completed Executive Leadership and Management Programs at the GE Management Development Institute.

    Yoav Katz

    Yoav Katz

    VP R&D

    Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem

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    Erez Adunsky

    Erez Adunsky

    Director of Operations & Manufacturing

    Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem

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    David Katz

    David Katz

    VP RA & QA

    Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem

    Contrary to popular belief, Lorem Ipsum is not simply random text. It has roots in a piece of classical Latin literature from 45 BC, making it over 2000 years old. Richard McClintock, a Latin professor at Hampden-Sydney College in Virginia, looked up one of the more obscure Latin words, consectetur

    Gracielle

    Gracielle

    Lorem Ipsum

    Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with the release of Letraset sheets containing Lorem Ipsum passages, and more recently with desktop publishing software like Aldus PageMaker including versions of Lorem

    Contrary to popular belief, Lorem Ipsum is not simply random text. It has roots in a piece of classical Latin literature from 45 BC, making it over 2000 years old. Richard McClintock, a Latin professor at Hampden-Sydney College in Virginia, looked up one of the more obscure Latin words, consectetur

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