As a Lab Manager you will manage a team of highly qualified QA and QC personnel responsible for lab activities, including but not limited to:
o Incoming Quality control (IQC): manage QA personnel handling all incoming QC activities for our products
o Outgoing Quality control (OQC): manage QA personnel handling all release tests and outgoing QC activities for our products
o Manage QA personnel handling clean room monitoring and microbiological release tests
o Responsible of batch release and batch record
o Responsible for test method validations
· You will serve as Quality Lead for non-conformances arising from QC activities
· You will perform analysis and presentation of quality monitors
· Leading additional activities in the QA department if needed
Job Requirements:
· Education:
o BSc in engineering related to medical device industry – a must
· Job skills:
o 4-6 years of experience in the medical devices industry, out of which at least 2 years in management position – a must
o Knowledge and experience in medical devices QA processes and clean room manufacturing– a must
o knowledge on GLP and Lab guidance – a must
o Knowledge and experience in manufacturing in Pharma – advantage
o Knowledge and experience in Automated process – advantage
o Work experience in relevant QA standards: ISO13485, QSR CFR, Part 820 – big advantage
o Experience in statistical analysis
· Computer skills: Proficiency in Office products - Must
· Language skills: Fluent English - Mother tongue level