- מיקום
- כל הארץ
- היקף משרה
- משרה מלאה
- תפקיד
- בקר/ית איכות
תיאור המשרה
- The Quality Engineer will provide quality oversight for new product development, sustaining engineering changes, risk management activities, and maintenance of Design History File %28DHF%29 documentation while ensuring compliance with applicable regulations and standards.
- Ensure compliance with Design Control requirements and internal procedures.
- Review and monitor of design planning, design reviews, design V&V, and design transfer activities for compliance.
- Ensure traceability between user requirements, design inputs, design outputs, risk controls, V&V activities.
- Review and approve ECOs, ECRs for risk, and compliance with QMS and standards.
- Verify that changes are properly documented, approved, implemented, and closed according to established procedures.
Requirements
- Bachelor%27s degree in Engineering, Biomedical Engineering, Mechanical Engineering, Quality Engineering, or related technical/medical discipline.
- Certified Quality Engineer %28CQE%29 or equivalent certification – advantage
- At least 5 years of Quality Engineering experience in the medical device industry.
- Experience with relevant standards %28ISO13485, ISO 14971%29.
- Experience supporting Design Control and Change Control processes.
- Experience reviewing DHF, DMR, V&V protocols and reports, and other technical documentation.
- Fluent English %28written and spoken%29.
- Proficiency in MS-OFFICE
