Junior QA Engineer (Temp)

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 Junior QA 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.

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

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.