Location: Yokneam
Work arrangement: Hybrid
Job description
Responsible for ensuring that R&D products meet quality and regulatory requirements throughout their entire lifecycle. The role includes managing DHF files, risk management and troubleshooting, participating in audits and product release activities, and leading quality improvement initiatives.
Key responsibilities
- Lead quality and regulatory activities during development and engineering stages
- Participate in design reviews, change control, and compliance with quality standards
- Manage DHF documentation for products and tools
- Own risk management processes, including FMEA
- Support internal and external audits
- Take part 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 within 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 mindset, and strong attention to detail