An International Medical Device company that develops and manufactures innovative medical equipment. Specifically, we develop infusion pumps and their related accessory products. We are looking for a talented and motivated engineer for the Quality Assurance Department.
The development QA Engineer will be a part of the product QA team;
He/she will be a QA focal point for the R&D projects for new and commercial products.
Attend R&D project routine meetings as the product QA team representative.
Review and approve deliverables and additional documents which are required for the R&D projects according to internal SOPs and regulatory requirements.
Participate in risk-evaluation processes related to R&D projects as the product QA representative.
Act as a QA leader of change controls initiated throughout the R&D products and for commercial products. Conduct QA activities relating to data analysis and statistics, calibrations, SOP reviews and approvals, audit tasks and support of non-conformity investigations.
Direct manager: QA Product Team Leader
Education: B.Sc. in Biomedical\Biotechnology\Chemical Engineering
Job Skills: 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) Auditor qualification - an advantage
Experience in supporting sterile production - an advantage
Computer Skills: Full proficiency of all MS-Office applications
Language skills: English - fluent (reading, writing and speaking)
Personality: Motivated, committed, creative, team player and proactive.