Temporary position – Development Quality Engineer (maternity leave cover)
Location: Yokneam
Work arrangement: Hybrid
Job description
Responsible for ensuring that R&D products meet quality and regulatory requirements throughout their lifecycle. The role includes managing DHF files, risk management, troubleshooting, participating in audits and product release activities, and leading quality improvement initiatives.
Key responsibilities
- Lead quality and regulatory activities during development and engineering phases
- Participate in design reviews, change control processes, and compliance with quality standards
- Manage DHF documentation for products and tools
- Own risk management processes, including FMEA
- Support internal and external audits
- Participate in product release activities and process improvement initiatives
Requirements
- BSc in a relevant field (Mechanical Engineering, Quality Engineering, or similar)
- Experience as a Quality Engineer, preferably in the medical device industry and in NPD environments
- Knowledge of standards and regulations: ISO 13485, ISO 14971, 21 CFR Part 820 (QSR), EU MDR
- Advantage: experience with Six Sigma methods and statistical distributions in product design
Required skills
- Ability to work independently, strategic thinking, and strong attention to detail