Required a QA Engineer for hi-tech company manufacturing medical devices, with offices in the Sharon.
We are looking for a talented and motivated engineer for the Quality Assurance Department.
The Engineer will be a part of the Quality and Regulatory department, working as part of the QA team.
Conduct QA activities relating to data analysis and statistics, calibrations, SOP reviews and approvals.
Responsible for the supplier management activities.
Perform Internal and Supplier audit.
Attend R&D project routine meetings as the QA representative.
Review and approve deliverables and additional documents which are required for the R&D projects.
Act as a QA representative of change controls initiated throughout the R&D products and for commercial products and for changes related to the QMS.
Maintain CAPA and Non-conforming activities.
Requirements:
B.Sc in Engineering in one of the following fields: Quality/ Biomedical / Biotechnology or in Bioscience education.
At least 2 years experience in QA or RA, preferably with R&D projects, in a medical device or pharma manufacturing company according to GMP and regulatory requirements (FDA QSR 820, ISO 13485).
Proven experience in Audits (CE, FDA).
Experience working in medical device product development (product design) and manufacturing (process design, process validation, and production).
Full control of all MS-Office applications.
Auditor qualification - an advantage.
Experience in supporting sterile production and clean rooms - an advantage.
Computer skills: Full control of all MS-Office applications.
Language skills: Fluent English - writing and verbal.