You can't change the direction of the wind, but you can adjust your sails to always reach your destination

QMS manager - Teunissen, Mascha - EHB (Heidi Jespers)

Koninklijke Philips N.V.

9071987 | EINDHOVEN | Detachering | HBO | publicatiedatum


Over de functie

Quality System BPE

Project: E2E Programs

Your challenge
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.

Location: Eindhoven, Netherlands with potential travel to Amsterdam, Netherlands

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.

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.


We are looking for 
• Bachelors degree or equivalent preferably in a scientific discipline 
• Minimum of 7 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. 
- This position requires an extensive knowledge of FDA QSRs, ISO 13485, GMPs 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 
• Skill set required for the department to operate: 
o Project management experience 
o Good communication skills written & verbal in English 
o Demonstrated experience in collaborative working environments 
o Experience addressing conflicts, escalation at team level to achieve desired results. 
o Demonstrated experience handling deadlines, able to focus on targets 
o Demonstrated experience-driving progress, taking initiative to achieve results. 
o Experience understanding the process approach End-to-End, where, the optimization of customer value chain starts from customer insight all the way to delivering products & service to the customers. 


Our  offer:
We will boost your career through personal and technical growth. We’ll support you by offering a personal coach and the possibility to follow courses and training via our highly recommended Yacht Academy. We’ll offer interesting benefits and a market conform salary. You’ll become member of the team of professionals who share your education, ambitions and your competencies. This will enable you to interact with your colleagues from Yacht in your own technology language! You’ll become a member of the yacht network, which stretches the high tech industry. You will be challenged by your peers. As a result you’ll be able to keep your knowledge and skills up-to-date! 


Yacht is a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on site and innovate together with our customers to find smart solutions. Being part of the world wide Randstad Group we have an extensive network of clients and professionals.
Working as a high tech professional within Yacht means you will work on interesting and challenging long term projects for our clients in the Dutch “Brainport” Eindhoven region, mainly on projects at our clients’ Research & Development departments. Our Brainport region is considered to be the smartest region in the world! We cooperate with high tech companies that work on the cutting edge of technology. To give you an example of our portfolio: ASML, Philips Healthcare, Philips Lighting, Philips Research, TNO, FEI company, DAF, VDL ETG, Océ and many others.


Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer 06-13888330

Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.


Uiteraard staat deze vacature open voor zowel mannen als vrouwen.