The job holder’s duties and responsibilities include any of the following:
Act as Insightec Quality Management Representative
Responsible for the Insightec quality management system
Lead the Quality Assurance team
Lead the company to meet its annual quality goals
Lead quality data analysis
Update company management on quality performance and policy implementation
Define and maintain quality aspects processes for relevant quality related Insightec activities
Lead and ensure company compliance with quality standards and certifications as required
Lead and prepare the company for internal and external auditing authorities as required
Support company teams with QA requirements and processes
Act as the person responsible for regulatory compliance (PRRC)
Experience of at least 10 years in a similar role in the Medical Device industry
BSC in Engineering or Sciences
Work experience with multi-disciplinary Systems
Regulatory experience with CE and FDA standards
Strong level of English (read, write and verbal skills)
Formal Auditing Conductance training
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