תיאור תפקיד:
As a Design Assurance Engineer, you will lead all quality elements of Design Controls and product DHF for new product introductions and sustaining/design projects.
Responsibilities
• Quality responsibility to verify that the design and development process follows the procedures and design and development plans.
• Work closely with R&D and test teams to support regulatory requirements by creating, reviewing, and providing quality and compliance input to the design and development process, deliverables, and requirements.
• Participation in project meetings to review and help update clear and concise user requirements, product specifications, plans, verification and validation studies, risk management files, and other relevant design control deliverables.
דרישות:
At least 2-3 years of experience working in a quality function in the medical device industry – must.
At least 1 year of experience as a design control engineer (preferred)
A Bachelor of Science in Engineering, Sciences, or a related field – must.
Familiar with statistical techniques used in verification and validation processes – must.
Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards – must. • Proficient use of standard MS Office applications.•
Fluent in English (oral and written)..• At least 2-3 years of experience working in a quality function in the medical device industry – must
היקף משרה:
משרה מלאה
קוד משרה:
JB-18929
אזור:
מרכז - תל אביב, פתח תקווה, רמת גן וגבעתיים, בקעת אונו וגבעת שמואל
שרון - חדרה וזכרון יעקב, נתניה ועמק חפר, רעננה, כפר סבא והוד השרון, ראש העין, הרצליה ורמת השרון
השפלה - ראשון לציון ונס- ציונה
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