Control of processes in compliance with the applicable regulations.
Defines and maintains the quality infrastructure in the company.
Approval of qualification and validation activities To realize quality plans.
Sub-contractors and suppliers approval.
Training and qualifying the company employees.
Sub-contractors and suppliers approval.
Liaises with regulatory authorities.
Lot release.
Approve finished projects and ECOs.
Approve design reviews as part of the R D plans.
Definition of testing, calibrating, maintenance and inspection procedures.
Approval of PMS processes.
Requirements: ASQ ICQM certification preferred.
Experience in Process Optimization and Variability Reduction/Cost. Reduction Projects or similar.
Regulatory knowledge specific to the FDA Quality system Regulations, ISO9001/ISO13485.
Medical Device Directive (MDD), Regulation MDR 2017/745 required, Japan, Canada, Australia and other countries.
Bachelors degree in Engineering; or over 10 years experience of Regulatory and Quality.
management in the medical device industry; a minimum 3 years experience in quality.
control function and 3-5 year.
Experience in process validation, working in a production environment would be advantageous.
Proven ability of working in a cross-functional team environment.
Excellent interpersonal and communication skills and high level of computer literacy.
Certified auditor for medical devices systems preferred.
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