מדעים/ביוטק

Senior QA/RA Project Manager

553894

תאריך עדכון

01/11/2021

תיאור המשרה

Senior QA/RA Project Manager for a medical device company

Responsibility for various QA/RA activities in the design and development processes in the company including:

Design and development processes and Design History Files (DHFs)

Verification and validation controls

 Regulatory submissions FDA CFR 820, CE-MDR

Work instructions and procedures

Employee training

Requirements:

Education in Life sciences/ Biomedical/ Mechanical/ Biotechnology/ Chemistry/ Materials Engineering- Mandatory.

Experience in a similar position in medical device for at least 2 years- Mandatory.

Knowledge and experience in FDA regulation (CFR820) and CE- Mandatory.

High level English

Multi-interface work capability

Excellent interpersonal

Full-time availability

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