Quality Engineer CAPA

Quality Engineer CAPA (Contract)

Location: HTC, Eindhoven / Best

Duration Assignment: 6 months (with possible extension and/or Philips transfer in time)

Contract: Permanent at a Randstad company

Hours/week: 40

Budget range: €3.500 - 4.900 per month

In this role, you will have the opportunity to: Make life better!

Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

In this assignment, one 

• Independently produces and completes CAPA records. 

• 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.

When you choose to work at Philips you’ll work on life-changing projects; and contribute to innovative health technologies and solutions that improve billions of lives around the world.

You will be responsible for:

• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring. 

• Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines. 

• Represent CAPAs during audits and CAPA Review Board meetings. 

• Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving). 

• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances. 

• 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. 

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

Education

• Bachelor’s degree in an engineering or scientific-related field or equivalent demonstrated strong technical competence.

Experience & Background

• Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001, and ISO 14971.

• 3+ years of related experience in medical devices or other regulated industries.

Required Competencies

• Able to understand and analyze complex problems, including software and hardware design issues.

• Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.

• Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.

• Demonstrated ability to partner 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.

• Excellent written and verbal communication skills.

You are a part of

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In return, we offer you:

For this project, you’ll work for Philips and become a contract or permanent employee of YACHT (a Randstad company). As a contractor at Philips you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional.

Why work on a project at Philips?

If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.