חזרה ללוח
Senior Design Quality Assurance Engineer
סטפ אפ קריירה
מיקום
צפון
תחום
מכשור רפואי
בכירות
ביניים
היקף משרה
משרה מלאה
גודל חברה
בינונית (51-200)
סוג תפקיד
איכות
תיאור המשרה
In this role, you’ll be a key partner to R&D, leading quality activities across new product development and design changes, while ensuring compliance with global regulatory standards.
Lead design control activities throughout the product lifecycle (ISO 13485, 21 CFR 820).
Review and approve design inputs/outputs, V&V protocols, and reports.
Maintain and execute risk management activities (ISO 14971), including FMEAs.
Support EO sterilization and packaging validation activities (ISO 11135 / ISO 11607).
Support root cause investigations, CAPAs, and engineering changes.
Ensure design documentation is support for global regulatory submissions.
Work closely with R&D, Operations, and Regulatory in a fast-paced, collaborative environment.
Support internal and external audits as needed.
דרישות התפקיד
B.Sc. in Biomedical, Mechanical, Materials Engineering or a related engineering field.
5+ years of QA / Quality Engineering experience in medical devices.
Strong, practical understanding of design controls and risk management.
Experience with verification & validation and test method development.
Hands-on experience with EO sterilization validation and sterile barrier systems.
Clear communicator, detail-oriented, proactive, and solution-driven.
Excellent documentation ability.
Nice to Have
Experience with neurovascular products or Class III medical devices.
Familiarity with ISO 10993, sterilization, packaging validation, and regulatory submissions.
Location: North District