Design Quality Engineer
Design Quality Engineer
10/05/2022
A Global Medical Device company, developing and manufacturing medical device designed for neuro-interventions (located in Yokneam) is looking for a Design Quality Engineer.
As a Design Quality Engineer, you will be responsible for quality system aspects of new products. In addition, you will also lead ECOs associate to design changes of released products and manufacturing process changes.
Scope & Responsibilities:
• QA focal point for new products and engineering projects in R&D.
• Responsible for product risk assessments and design reviews, work closely with R&D to develop appropriate qualifications for both new design and changes to already released designs.
• Responsible for DHF and DMR documentation.
• ECOs management including assignments tracking and reporting quality metrics for the management.
• Support US FDA regulatory submissions, EU MDD/MDR Technical Files, and international packages.
• Participates in internal and external audits i.e. internal audits, FDA inspections, notified body audits according to ISO13485, EUMDR, MDSAP.
Requirements:
• Degree in Biomedical Engineering / Biotechnology / Life Sciences.
• Fundamental knowledge of ISO13485:2016 and FDA requirements (e.g. CFR Part 820) EU Medical Device Directive & new MDR, ISO 14971.
• DHF compilation, including Design Controls process and other applicable regulatory, QA and GMP aspects.
• At least 3-5 years of relevant previous experience in quality assurance of medical devices
• English - high level (both written and spoken).
• Excellent teamwork ability and interpersonal skills.
• Service oriented.
• Ability to work in dynamic and multi-interfaced surroundings, micro and macro vision.
• Strong attention to details.
• Computer skills (Microsoft Word, Excel, PowerPoint).
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