מדעים/ביוטק

Quality Assurance Manager

118287

תאריך עדכון

05/03/2020

תיאור המשרה

The Quality Assurance Manager will work close to the Director of QA and to the VP of Clinical, QA and RA in monitoring all company’s processes and procedures with focus on production and supply chain processes, verifying alignment with requirements and ISO 13485. In addition, he/she will take part in the Regulatory tasks (FDA and CE submissions).
 
Primary Responsibilities:
    • Opening and following up on open CAPA, working close with R&D , support, operations and supply chain on root cause investigation and opening corrective actions
    • Reviewing technical drawings, production portfolios, calibration excels and vendor reports to make sure all is aligned with ISO and procedure requirements
    • Maintenance of QA training schedules and effectiveness management
    • Working close with the QA Director, R&D and production on approving ECO’s for new products and changes in existing ones
    • QC management – before release of a new product, verifying production is done according to procedures and going over production papers and handling non conformities (MRB)
    • Conducting internal and supplier audits
    • Working close with the R&D, Project Management, Support and Engineering teams
 
Position Requirements:
    • BSc in Engineering / Life Science / Certified QA
    • Knowledgeable on ISO 13485 and QA systems and processes
    • At least 3 years of experience in Quality Assurance from the medical industry, preferably in an FDA environment
    • At least 1 year experience with  FDA and CE submissions – an advantage
    • knowledge in regulatory processes (FDA and CE submissions)
    • Highly proficient in English – reading and writing technical documents
    • Highly organized, analytic, detailed, with an high level sight and understanding
    •  Good technical understanding and approach
    • Excellent communication and interpersonal skills. Ability to influence and to deal assertively and sensitively with complex interpersonal situations
    • Ability to work independently and prioritize
    • Experience with Technical drawings – an advantage
    • Knowledge in validation processes – an advantage
    • Knowledge in DHR and DMR  – an advantage
 
המשרה אוישה למשרות נוספות לחץ כאן
המשרה מיועדת לנשים ולגברים כאחד