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. 

Job description:

Responsibilities

• 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.

Qualifications

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.