With the exception of independent contractors, applicants for this role will be engaged through Randstad company. When making this application your details will be automatically shared with Randstad company for registration with them, who may also contact you about other opportunities with other clients.

Philips

Quality manager

Posted Mar 25, 2021
Project ID: PHILJP00022903
Location
Eindhoven , Noord Brabant
Duration
6 months
(Apr 1, 2021 - Sep 30, 2021)
Hours/week
40 hrs/week
Payrate range
60 - 80 €/hr

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

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