QMS Compliance Engineer

2 days ago

Ramat Gan, Tel Aviv, Israel Pulsenmore Full time

Pulsenmore is a world leader in connected, patient-driven home ultrasound. We are on a mission to improve access to care while increasing convenience and efficiency for patients and healthcare providers alike. Our flagship product, the Pulsenmore ES, is a hand-held ultrasound device that docks with a patient's smartphone. It allows every expectant mother to self-scan and receive a remote clinical assessment from the healthcare provider.

We seek a QMS Compliance Engineer (Temp). This is an exciting opportunity to join a rapidly growing global Med-Tech company and play a key role in ensuring the quality and reliability of our products.

Responsibilities

Job description:

The QA engineer will part of the QA/RA team at Pulsenmore and will be responsible for:

  • Implement and deploy Quality assurance policies and processes.
  • Interpret and comply with quality assurance standard and regulations.
  • Lead CAPA activities and measure their effectiveness.
  • Perform internal audits and manage the audit schedule.
  • Participate in external and internal audits and inspections.
  • Lead Complaints investigations as Complaint Unit.
  • Manage the documentation and record control activities.
  • Monitor training and qualification activities.
  • Provide inputs to management reviews.
  • Support production QA activities (QA release, MRB) as needed.
  • Support design control activities as needed.
Requirements

Requirements/Qualification:

Education:

  • Practical Engineer/BSc in electrical/mechanical/biomedical engineering

Experience:

  • Previous experience in medical device / Quality assurance an advantage
  • Previous experience in performing investigations, critical thinking an advantage
  • Experience in root cause analysis

Technical skills:

  • Language skills, Hebrew, English fluent reading/writing/speaking
  • Other languages an advantage
  • Computer skills: Office (word, Excel PowerPoint Visio)

Personal skills:

  • Team player
  • Reliable and accurate
  • Good verbal communication
  • Works well under pressure
  • Attention to details
  • Logical thinking
  • Fast learner

Qualification requirements:

  • QA procedures and Wis related to the responsibility areas
  • Internal auditor
  • ISO 13485, FDA QSR, MDD, MDR

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