CAPA Engineer

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  • Dienstverband Fulltime
  • Vacaturenummer VAC-10014706
  • Locatie High Tech Campus 5 Eindhoven Noord Brabant NLD 5656 AE
  • Type overeenkomst Secondment via YER

Over deze vacature

In this role, you have the opportunity to guide and support business groups, markets and enabling functions to always do the right thing. As a QMS (Quality Management System) Manager within the PQMS markets central team, you will drive QMS compliance in the markets and associated functions. Office location is Eindhoven, but you will be home-based.

The PQMS markets central team which plans, controls and manages relevant QMS activities for all The PQMS markets central team consist of 30 QMS professionals mainly based in Eindhoven, the Netherlands as well as other regions worldwide. You will be reporting to the PQMS Markets Programs & Projects Lead.

Functie

CAPA Engineer
In this role, you have the opportunity to
Guide and support business groups, markets and enabling functions to always do the right thing. As a
QMS (Quality Management System) Manager within the PQMS markets central team, you will drive
QMS compliance in the markets and associated functions. Office location is Eindhoven, but you will be home-based.

You are responsible for
• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue
identification through implementation of solution and effectiveness monitoring.
• Act as a Project Manager with internal CAPA owners to manage all aspects of CAPA activities which
include gaining the commitment of cross functional resources, scheduling CAPA team meetings, and
ensuring CAPA deliverables per project timelines.
• Train and mentor CAPA owners in all required elements and best practices of CAPA, including
containment, root cause analysis, correction, corrective and preventive actions and effectiveness
checks.
• Work effectively with all levels of management to ensure CAPA action plans can be supported and
that costs/resources needed to implement the plan are available.
• Responsible for performing timely, detailed CAPA engineering tasks like: assessing issue descriptions,
reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.
• Ensure CAPA action plans are robust and executed promptly, with the appropriate sense of urgency
Represent CAPAs during audits and CAPA Review Board meetings.
• Analyze quality monitoring data sources and apply statistical techniques to identify existing and
potential causes of non-conformances.
• Perform periodic trend analysis and corrective action effectiveness measures of all quality system
events and identify opportunities for improvement.

To succeed in this role, you should have the following skills and experience
• Bachelors degree in an engineering or scientific-related field or equivalent technical experience
• 5+ years work experience in quality functions, experience with CAPA is required; experience in
Medical/automotive related industry is preferred.
• Able to understand and analyze complex problems, including software and hardware design issues.
• Demonstrated deep knowledge of tools and techniques required to perform thorough root cause
analysis and develop strong investigations,
• Work knowledge of appropriate global regulations, requirements, and standards such as 21CFR Parts
803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
• Demonstrated ability to collaborate with the business and effectively interact with and influence
employees, and managers on all levels.
• Strong Project Management skills, including ability to project manage all CAPA activities.
• Ability to analyze data and apply statistical techniques.
• Ability to assess risk as it pertains to the CAPA

You are a part of
The PQMS markets central team which plans, controls and manages relevant QMS activities for all
International Markets within Philips. The core business of the markets is the sales, marketing,
distribution, installation and servicing of Philips medical and non-medical devices and solutions
designed & manufactured by the Business Units: Personal Health, Precision Diagnosis, Image Guided
Therapy and Connected Care.
The PQMS markets central team consist of 30 QMS professionals mainly based in Eindhoven, the
Netherlands as well as other regions worldwide. You will be reporting to the PQMS Markets Programs
& Projects Lead.

Proposed adjustments for the role dd 8/10:
- Profile should be for a process engineering background with a good understanding of quality systems
- Experienced in the process as CAPA owner
- Good Technical Writing skills
- Data driven
- Very hands on person
- Ability to work in different projects (CAPAs) at the same time
- Ability to interact in a multicultural environment
- Experience with Trackwise is a plus
- Experience in medical devices desired, if not, proven experience on a high regulated environment

Bedrijf

With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision-making.

Aanbod

You will be employed by YER and seconded to Philips. We offer:

  • Good employee benefits
  • Excellent guidance from your consultant and YER's back office
  • Friendly atmosphere and open culture
  • Community/network with other technology professionals from a variety of multinationals
  • Events and master classes with interesting speakers and attractive companies

Profiel

  • To succeed in this role, you should have the following skills and experience
  • Bachelors degree in an engineering or scientific-related field or equivalent technical experience
  • 5+ years work experience in quality functions, experience with CAPA is required; experience in Medical/automotive related industry is preferred.
  • Able to understand and analyse complex problems, including software and hardware design issues.
  • Demonstrated deep knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations
  • Work knowledge of appropriate global regulations, requirements, and standards such as 21CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
  • Demonstrated ability to collaborate with the business and effectively interact with and influence employees, and managers on all levels.
  • Strong Project Management skills, including ability to project manage all CAPA activities.
  • Ability to analyse data and apply statistical techniques.
  • Ability to assess risk as it pertains to the CAPA
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