Quality Assurance Specialist

IceCure is looking for a quality assurance personnel to join a talented team to continue improving the quality management system, processes, and products

Job Description and Responsibilities

Ø Review and approve production records.

Ø Control of production per procedure requirements.

Ø Write, review, and approve procedures and work instructions.

Ø Provide support in the maintenance of the quality system.

Ø Conduct incoming inspection, product/Batch release, QC, and in-process control activities.  

Ø Participate in QMS establishment and improvement.

Ø Collaborate with Operations, QA, Engineering and Manufacturing, and CMs functions to ensure high-level quality standards.

Ø  Support manufacturing transfer quality engineering activities.

Ø Represent Quality in project core teams.

Ø  Support day-to-day manufacturing activities performed in-house and at CMs.

Ø Take an active role in reviewing and approving design and manufacturing changes.

Ø  Participate in product quality investigations in support of CAPA, complaints, and Nonconforming material processes.

Ø Participate in ongoing processes to improve products and services.

Ø Control and manage measuring devices at the company and CM’s

Ø Verify the compliance of company quality and control system requirements with predefined procedures and working instructions.

Education and experience

Ø Bachelor's degree in quality, Bioengineering, Life science, or similar discipline with relevant education in QA. 

Ø At least 3 years’ experience in QA/QC at a multidisciplinary Medical Device Company.

Ø Good Communication skills both verbally and in writing.

Ø Good analytical skills.

Ø High ability to work independently.

Ø Self-motivated and proactive.

Ø Fluent in English with excellent writing skills.

Ø Excellent computer skills, including a working knowledge of Microsoft Office applications.