we are a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. We are looking for an excellent Design Quality Engineer to join the QA product team
Job Description As a Design Quality Engineer, you will be the focal point for R&D projects' new products. You will attend R&D project routine meetings as the product QA team representative. You will review and approve deliverables and additional documents which are required for the R&D projects according to internal SOPs and regulatory requirements. You will participate in risk-evaluation processes related to R&D projects as the product QA representative. Act as a manager 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.
Requirements: Education B.Sc. in Biomedical/Biotechnology/Chemical Engineering or equivalent Job skills o 2 -5 years of experience in QA /RA, preferably with R&D projects, in a medical device or pharma manufacturing company o Deep knowledge in working according to GMP and regulatory requirements (FDA QSR 820, ISO 13485) o Auditor qualification - an advantage Computer skills Proficiency in Office products - Must Language skills Fluent English - Mother tongue level Personality o Team player o Excellent interpersonal relations o Highly organized and detail oriented o Motivated and committed o Creative and proactive
This position is open to all candidates.