Design Quality Engineer
6 days ago
Eitan Medical
is 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:
- 2 -5 years of experience in QA/RA, preferably with R&D projects, in a medical device or pharma manufacturing company
- Deep knowledge in working according to GMP and regulatory requirements (FDA QSR 820, ISO 13485)
- Auditor qualification - an advantage
- Computer skills: Proficiency in Office products - Must
- Language skills: Fluent English - Mother tongue level
- Personality:
- Team player
- Excellent interpersonal relations
- Highly organized and detail oriented
- Motivated and committed
- Creative and proactive
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