Quality manager

The position reports to the Head of Q&R for the Connected Care Informatics Business

Description

-   Maintains a robust and efficient QMS and behavior that will be accepted by our customers and regulators as best in class.

-   Represent the business during any audit, internal or external.

-   Drive compliance across all functions of the business and ensure preparedness for any audits. Audit findings, to reinforce compliance or remedial action on any unsatisfactory findings.

-   Implements appropriate activities to ensure efficiency with complaint handling, corrective and preventive action, and the internal audit program.

-   Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.

-   Recommending and implementing changes to methods.

Requirements:

-   Bachelor's degree (Science, Engineering or similar technical field) required, Master's degree in business, management or quality strongly preferred

-   Minimum 10 to 12 years working experience of which a couple of years progressive management experience in a responsible Quality Assurance/Regulatory Affairs role (required)

-   Experience in Quality Systems is required and experience in Regulatory Affairs is an advantage. Good understanding of ISO13485, EUMDR standards

-   Experience in Software development and products is required

-   Medical Device experience is required.

-   Strong partner leadership skills

-   Experience with FDA and other world-wide standards and regulations is preferred

-   Achievement oriented and customer focused

-   Would help if there is knowledge of Philips PEPF

-   Experience of facing external audits for 13485, EUMDR, MDSAP etc

-   Knowledge of SW related standards and working experience in QA function of a SW product