Quality Design Assurance Engineer
מעבר למשרות נוספות המימד השלישי פתרונות משאבי אנוש בע
פורסם לפני 3 ימים
- חדרה, כפר סבא, נתניה, תל אביב - יפו
- משרה מלאה
- 22,000 ₪ - 28,000 ₪
פרטי מגייס/ת המשרה:
תיאור המשרה:
A medical device SU is seeking to hire a Quality Design Assurance Engineer to join our QA team.
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.
• Quality responsibility for transferring new products and sustaining projects to manufacturing and operations quality and supplier quality teams.
• Support the Regulatory Affairs department for submissions and respond to submission questions, implementation of new or revised standards and support internal and external audits.
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.
• Quality responsibility for transferring new products and sustaining projects to manufacturing and operations quality and supplier quality teams.
• Support the Regulatory Affairs department for submissions and respond to submission questions, implementation of new or revised standards and support internal and external audits.
דרישות המשרה:
• 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.
• Strong analytical and problem-solving skills, with keen attention to detail.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
• Proficient use of standard MS Office applications.
• Fluent in English (oral and written).
• 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.
• Strong analytical and problem-solving skills, with keen attention to detail.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
• Proficient use of standard MS Office applications.
• Fluent in English (oral and written).
מעבר למשרות דומות בתחומים:
משרה מספר 9280987
metapel
על החברה:
המימד השלישי פתרונות משאבי אנוש בע
גודל חברה: 11-50
תעשייה: משאבי אנוש
חב’ המימד השלישי מתמחה בניהול תהליכי גיוס עבור ארגונים המחפשים פתרונות יצירתיים ולא קונבנציונליים.
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