ICECURE JOB DESCRIPTION
IceCure Medical, an innovative and fast-growing medical device company and leader in the Cryoablation market, is looking for a Quality Engineer to join the Quality Assurance, Regulatory Affairs and Clinical department in Caesarea, Israel.
The Quality Engineer will report to the Quality Assurance Director.
- Collaborating with Operations, QA, Engineering and Manufacturing and CMs functions to ensure quality standards are in high level
- Leading manufacturing transfer quality engineering activities
- Maintaining and control of QMS under ISO 13485 and MDR
- Representing Quality in the project core team
- Supporting day-to-day manufacturing activities performed in house and at CMs.
- Leading manufacturing quality escalations to resolution.
- Taking an active role in leading, reviewing and approving design and manufacturing changes.
- Leading product quality investigations in support of CAPA, complaints and non-conforming material processes.
- Collecting, analyzing and interpreting statistical data, performing analyses and providing reports as required.
- Leading Quality Assurance and product quality improvements for cross functional initiatives.
- Controlling suppliers quality, performing suppliers audits and suppliers CAPA.
- Training of employees and maintaining training documentation.
Education and experience:
- Bachelor’s degree in mechanical, biotechnology, bio-medical, industrial or similar engineering disciplines.
- 3-5 years experience in Quality Assurance, at a multidisciplinary Medical Device Company.
- Certified Quality Engineer (CQE) or other similar quality/reliability certifications – Advantage.
- Familiarity with medical device regulations (ISO, EU, CFR).
- Strong understanding of product lifecycle process
- Good Communication skills both verbally and in writing
- Good analytical skills
- High ability to work independently
- Self-motivated and proactive
- Fluent in English with excellent writing skills
- Excellent computer skills, including a working knowledge of Microsoft Office applications.