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Position Title: QA specialist
Reports to: QA team lead
Department: Quality, Clinical and Regulatory Affairs
Job description and Responsibilities
Review and approve production records.
Control of production per procedure requirements.
Write, review and approve procedures and work instruction.
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 teams.
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.Education and experience
Bachelor’s degree in quality, Bio engineering, Life science or similar discipline with relevant education in QA.
At least 3years’ 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 a working knowledge of Microsoft Office applications.