מדעים/ביוטק

Senior QA manager

889161

תאריך עדכון

23/06/2022

תיאור המשרה

Responsibilities:

· To lead, coordinate and plan the work within the dedicated QA/QC Team.

· Evaluate and improve QA processes.

· To coach and lead the dedicated QA/QC Team in order to develop adequate competencies, efficient working methods, optimal use of resources and a stimulating working climate

· To maintain and continuously improve procedures and instructions related to area of responsibility, compliant to FDA, MDD/MDR and all applicable regulatory and corporate requirements.

· Secure CAPA Process are implemented and followed within the organization.

· Foster a philosophy of continuous improvement in the organization, including Management of Nonconformities when needed.

· Perform Quality Review of documents related to the QMS.

· Actively take part in the Change Control Process as QA representative. Member of the PCO Board.

· Actively take part in Design Transfer activities such as Purchase Approval and Production Start Process

Requirements:

· Bachelor’s degree in sciences

· Experience from working within QA/QC in a Medical Device Industry, preferable class III

· Experience from acting as People Manager within QA/QC,

· Experience from participate in External Audits for example Notified Body Audits

· Knowledge within ISO 13485, FDA Quality System Regulation 21 CFR Part 820

· Knowledge about EU MDR (Medical Device Regulation and EU MDD (Medical Device Directive)

· Very good English – for writing professional documents.

· Very good knowledge with Word/Excel/Power point 

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