Quality Assurance Specialist

QA Specialist

IceCure Medical, an innovative and fast-growing medical device company and leader in the cryoablation market, is looking for an experienced and motivated QA Specialist to join our Quality team.

• Review and approve production records.
• Control of production per procedure requirements.
• Write, review, and approve procedures and work instructions.
• Provide support in the maintenance of the quality system.
• Conduct incoming inspection, product/batch release, QC and in process control activities.
• Participate in QMS establishment and improvement.
• Collaborate with Operations, QA, Engineering and Manufacturing and CMs functions to ensure high-level quality standards.
• Support manufacturing transfer quality engineering activities.
• Represent Quality in project core
• Support day-to-day manufacturing activities performed in-house and at CMs.
• Take an active role in reviewing and approving design and manufacturing changes.
• Participate in product quality investigations in support of CAPA, complaints, and Nonconforming material processes.
• Participate in ongoing processes to improve products and services.
• Control and manage measuring devices at the company and at CM’s.
• Verify the compliance of company quality and control system requirements with predefined procedures and working instructions.

• Bachelor’s degree in quality, bioengineering, life science, or similar discipline with relevant education in QA.
• At least 3 years’ experience in QA/QC at a multidisciplinary medical device company.
• 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 working knowledge of Microsoft Office applications.

Reports to: QA team lead