Quality System Business Process Expert

Noord Brabant - Nederland - Life Sciences & Health Care - Healthcare - Project Management & Services - HBO

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Sophie Claessens, Consultant


Over deze functie

The Quality System Business Process Expert supports the development, deployment and maintenance of the Philips Quality Management System (PQMS), ensuring Philips cross sector standardization and regulatory compliance. Together with a cross functional project team you will work on the roll out of End-to-End (E2E) processes and software applications from the Philips Integrated Landscape (PIL), ensuring compliance to regulations is maintained throughout the project.

Your main responsibilities are:

• Support E2E Programs and business / market PQMS teams with the deployment of E2E processes and PIL software applications• Support the E2E Programs to ensure E2E process content and validated software applications are available in time to meet deployment timelines
• Ensure QMS deliverables are embedded in the project plans to ensure compliance to regulations.• Keep oversight of deployment projects and ensure E2E process content, validated software applications and QMS deployment deliverables will be available per the agreed schedule, escalate (possible) delays.
• Support business / market PQMS teams with timely completion of impact assessments, identification of appropriate Q&R activities and closure of defined actions• Support business / market PQMS teams to maintain oversight of scheduled projects
• Provide visibility on PEPF QMS Deployment statuses and Project Deployment Readiness.

Over jou

• Minimum of 5 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical (device/Pharma) industry. • Proven experience in Quality Management System processes, including cross sector or business process standardization (desired), ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations.
• A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance. o This position requires an extensive knowledge of FDA QSR’s, ISO 13485, GMP’s and other worldwide Quality System Regulations.
• An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization • Experience with deployment of Quality Management System processes as identified

Wat wij bieden

Being employed by Brunel means that you are contracted by one of the top technical agencies. Not only you will have a contract, you will as well be assured of a great career! Our primary and secondary terms of work are excellent. A few examples are price reductions at CZ Health Insurance, bonus opportunities and standard 26 days off. Brunel Engineering intermediates both junior and senior engineers within the industry for over 30 years now. Our clients vary from multinationals to local companies. Together we will find the job which meets your wishes.

Over ons

Your team • Quality Assurance is an integral aspect of the global healthcare business including device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance. This position is intimately involved in the process of ensuring Quality System Regulations are embedded within business processes and supports the standardization of the Philips Quality Management System.


  • Vacature nummer: PUB250711
  • Standplaats: Noord Brabant
  • Markt: Life Sciences & Health Care
  • Uren per week: 40
  • Branche: Healthcare
  • Opleidingsniveau: HBO
  • Expertisegebied: Project Management & Services
  • Sluitingsdatum: vrijdag 13 maart 2020

Vragen? Neem contact op


Sophie Claessens

Consultant Brunel Netherlands Eindhoven

+31 40 257 8244

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