QMS Compliance Engineer (Temp)
About The Position
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