Philips Quality Assurance Process Manager in Eindhoven, Netherlands

Your challenge

Cardiology is one of the four growth pillars of Philips. To accelerate our growth ambition of doubling our business by 2020, we are currently looking for a Quality Engineer for our Cardiology Informatics (CI) business. You will be working in a cross-functional international team which develops cardiology informatics products. You will perform activities to ensure compliance to regulatory requirements and procedures as documented in the Quality Management System of CI and as required by for medical devices which are sold worldwide.

Your responsibilities

  • Verification of execution of processes and their deliverables in product creation and subcontracting projects and report the findings to upper management.

  • Review and Approval of designated project documentation in product creation projects.

  • Advise to product creation projects concerning the definition and implementation of quality assurance activities

  • Advise upper management with respect to release for delivery of products

  • Support and represent Q&R discipline in Design Reviews, Hazard Analysis brainstorms, Health Risk Assessments

  • Represent the approbation officer in projects and support in the activities to acquire product licenses and approvals

  • Participation in and verification off changes to DMR and release orders where Q&R involvement is needed.

  • Participates in the maintenance and improvement of the Quality Management System

  • Drive the execution of and/or support and advice the organization in corrective and preventive actions

  • Initiate, stimulate, support the implementation of process improvements

Your team

The Quality Assurance (QA) and Quality Engineering (QE) team of CI is located in the Netherlands and being built in Blumenau Brazil. It is part of the Business Group (BG) Healthcare Informatics (HI) international QA/QE team of about 20 people. In this role, your manager is the Head of QA/QE of the BG HI. For your daily activities you will report to the Q&R lead of CI and to the project managers of the innovation projects to which you are assigned.

Our offer

  • We welcome you to a challenging, innovative international environment with great opportunities for you to explore.

  • You will be working at the heart of one of the growth areas within Philips.

  • Many opportunities to learn and grow, using an extensive set of tools and support from our business.

  • A workplace geared to support new development methods.

  • An enthusiastic and fast growing team that works closely together and collaborates globally.

We are looking for

  • Bachelor/Master Degree in Informatics or other relevant science

  • 3-5 years of total industry experience with at least 2 years of related experience in a medical device or other regulated industry is required

  • Knowledge of FDA QSR, ISO 13485, ISO 14971 and related relevant regulations and standards

  • Working knowledge of appropriate global medical device regulations or other regulated industry, requirements and standards is required

  • Expertise/experience in root cause analysis, corrective/preventive action methods and problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA/ 5WHY etc.

  • Good knowledge of Software/quality development and control methods;

  • Very good communication and documentation skills

  • Fluent in English; speaking, reading and writing.

  • Proactive, independent, target oriented and self-motivated

Cardiology is one of the four growth pillars of Philips. To accelerate our growth ambition of doubling our business by 2020, we are currently looking for a Quality Engineer for our Cardiology Informatics (CI) business.

In this role, you have the opportunity to

work in a cross-functional international team which develops cardiology informatics products. You will perform activities to ensure compliance to regulatory requirements and procedures as documented in the Quality Management System of CI and as required by for medical devices which are sold worldwide. You are responsible for reporting the project status as an independent reviewer. Next to that you are both partner for the project team and responsible as liaison between the project team and the Quality and Regulatory (Q&R) department. You also are responsible to complete your own Quality and Regulatory project deliverables.

You are responsible for the

  • Verification of execution of processes and their deliverables in product creation and subcontracting projects and report the findings to upper management.

  • Review and Approval of designated project documentation in product creation projects.

  • Advise to product creation projects concerning the definition and implementation of quality assurance activities.

  • Advise upper management with respect to release for delivery of products.

  • Support and represent Q&R discipline in Design Reviews, Hazard Analysis brainstorms, Health Risk Assessments.

  • Represent the approbation officer in projects and support in the activities to acquire product licenses and approvals.

  • Participation in and verification off changes to DMR and release orders where Q&R involvement is needed.

  • Participates in the maintenance and improvement of the Quality Management System.

  • Drive the execution of and/or support and advice the organization in corrective and preventive actions.

  • Initiate, stimulate, support the implementation of process improvements.

You are a part of

The Quality Assurance (QA) and Quality Engineering (QE) team of CI is located in the Netherlands and being built in Blumenau Brazil. It is part of the Business Group (BG) Healthcare Informatics (HI) international QA/QE team of about 20 people. In this role, your manager is the Head of QA/QE of the BG HI. For your daily activities, you will report to the Q&R lead of CI and to the project managers of the innovation projects to which you are assigned.

To succeed in this role, you should have the following skills and experience

  • Bachelor/Master Degree in Informatics or other relevant science

  • 3-5 years of total industry experience with at least 2 years of experience in medical device (preferred) or in other regulated industries like pharma, automotive or aerospace (required)

  • Experience with dealing with software development (Agile, Safe) is preferred

  • Good knowledge and experience with Quality Assurance & control methodologies (requirement)

  • Experience with adopting and deploying QMS

  • Knowledge of FDA QSR, ISO 13485, ISO 14971 and related relevant regulations and standards (preference)

  • Working knowledge of appropriate global medical device regulations or other regulated industry, requirements and standards is required

  • Expertise/experience in root cause analysis, corrective/preventive action methods and problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA/ 5WHY etc.(preferred)

  • Very good communication and documentation skills

  • Fluent in English; speaking, reading and writing.

  • Proactive, independent, target oriented and self-motivated

In return, we offer you

We welcome you to a challenging, innovative environment with great opportunities for you to explore.

Our benefits are very competitive and designed around your preferences:

  • A market conform salary

  • 25 Days of leave and the possibility to purchase up to 20 extra days off annually

  • A variable bonus based on both Philips results and personal performance

  • Extensive set of tools to drive your career, such as a personal development budget, free training and coaching

  • Solid company pension scheme and attractive collective health insurance package

  • Opportunity to buy Philips shares and products with discount

  • Healthy work-life balance

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .