Process Quality Engineer

Process Quality Engineer (Contract)

Location: Best

Duration Assignment: 12 months (with possible extension and/or Philips transfer in time)

Contract: Permanent at a Randstad company

Hours/week: 40

Budget range: €3.836 - 5.115 per month

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

Take part in the transformation journey towards a world class Operations organization to better serve our customers with speed and excellence. You will be a part of the Factory Best organization, which is one of the main Operation sites for Health Systems within Philips. Our Factory Best organization is driving operational excellence and manufactures, refurbishes and repairs our medical devices & components in a safe, compliant, and effective manner. The Factory Best team is also responsible for the preparation and introduction of changes on products/components/production processes for released products and receiving and implementing manufacturing transfers from Industrialization engineering.

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: 

• Factory Best representative in all New Product Introduction projects, Life Cycle Management, and manufacturing location transfer projects to establish a robust manufacturing process to meet regulatory requirements for design transfer, process and tool validation.

• Drive product quality targets such as First Pass Yield (FPY), product and process quality notifications (QN’s)

• Being in lead for establishment and completion of Receiving Inspection Plan (RIP)

• Participate in design transfer and process design activities such as review of Device Master Record, DFMEA, manufacturing design and Process FMEA

• Participation in standardization of processes, PEPF (Philips Excellence Process Framework)

• Mentor and coach managers/engineers on design transfer, process design and the validation life cycle process

• You support the process owner to define the validation life cycle process, by creating the procedure and templates. Once validation state is reached, it is maintained according to change process.

• You ensure that the validation life cycle process meets regulatory and Quality Management System requirements (21CFR part 820.75, 820.70(i), 820.72(a), ISO 13485, and compliance with FDA guidance documents such as GHTF, etc).

• Ensure the content of the process is consistent within the Quality Management System by review & approval

• Ensure that the automated data processing systems and tools are validated against intended use and user need according to GAMP5 methodology

• You accompany internal & external audits related to process validation, such as FDA, 3rd party and notified body audits and ensure initiation and follow up of corrective and preventive actions

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

• Bachelor of Science degree in a technical or business discipline

• Minimum 3 years of experience in a medically regulated and technical environment within a medical device company

• Knowledge of manufacturing and design process and process FMEA, preferably experience in design and establishment of manufacturing processes, Design FMEA, DMR, Design for Assembly, manufacturability and testability

• Excellent knowledge of medical device regulations 21CFR FDA parts 820.30(h), 820.75, 820.70(i), 820.72(a), 820.80 and ISO 13485 and guidance documents, knowledge of ISO14971

• Statistical knowledge, particularly Gage R&R ANOVA, Attribute Analysis agreement and process capability such as PpK study, First Pass Yield

• A good communicator on different organizational levels in English

• Strongly preferred: proven experience in multi-site, multi-disciplinary quality organizations

You are a part of

The New Product Introduction (NPI) & Validation team, which is a part of Factory Best Quality department. The Quality department for Factory Best reports into the Q&R. The Quality department focuses on ensuring product quality, while maintaining full compliancy and driving manufacturing excellence. The aim is to achieve timely releases of products with high quality and outstanding reliability.

Philips

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.