QMS Compliance 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 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.

Position: QMS Compliance Engineer (Temp)

This role reports to the VP QARA

Focusing mainly on Complaints, CAPA and general QMS

Job description:

The QMS Compliance Engineer (Temp) take 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/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