Quality Specialist - Corrections and Removal

Quality Specialist - Corrections and Removals (Contract)

Location: 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!

• Be part of a fast-growing business that helps improve the lives of millions of people, while advancing Philips digital transformation journey as a global leader in Health Technology.

• Being part of the correction and removal process will allow you to work with cross functional teams to ensure that appropriate actions are taken on distributed products, ensuring patient safety, product quality and customer satisfaction.

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:

• Support the execution of post-market risk assessment (Issue Impact Assessment).

• Drive the preparation of Health Hazard Evaluation in cooperation with Product technical experts and Medical Affairs.

• Work in multifunctional teams contributing with Knowledge and experience to ensure proper preparation and execution of C&R, Risk Assessments, etc. often leading a cooperative effort among members of those teams.

• Drive the C&R strategy ensuring reportability decisions per Country and execution of activities according to the C&R strategy.

• Create all C&R related Customer Notifications and C&R Regulatory Submission reports (e.g. FSCA, 21CFR806).

• Manage the C&R file documentation and C&R file completion, ensuring that C&R records meet Good Documentation Practices.

• Support the preparation of responses to Regulatory agencies inquiries and provide follow up.

• Continuously track C&R execution and provide ongoing information to IGT Systems C&R management and teams as required.

• Act as a Quality and Regulatory expert for the C&R process.

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

• BS in a Technical Discipline preferably in Healthcare, Engineering or Science.

• 6+ years of related experience in a medical device or regulated industry preferably in Correction and Removal processes, regulatory submission, Risk Management

• Project Management skills. 2+ yeas of project management is an advantage.

• In-depth knowledge of Quality management systems and deep understanding of related regulation (e.g. 21 CFR Parts 803, 806, and 820, EU MDR – Regulation (EU) 2017/745, ISO 13485, ISO 14971, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169). Proven work experience is preferable.

• Good analytical skills and process improvement capabilities.

• Strong written and oral communications skills in English and demonstrated ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers).

• Ability to successfully balance and prioritize multiple ongoing projects/tasks.

• Strong attention to detail and accuracy.

• High reliability and quality focus.

• High degree of initiative, engagement, self-motivation and flexibility.

• Able to work in a changing environment and be a full supporter of change.

You are a part of

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.