Quality Compliance Specialist

il y a 2 semaines

Zaventem, Belgique Philips Temps plein

**Job Title**: Quality Compliance Specialist

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 this role, you 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.

**You are responsible for**

Assisting Quality Manager (as auditee) for Audits (internal & external)

Quality CAPA Owner/Approver for all CAPAs

Quality Facilitator/Approver for all NCRs

Assisting the EC MDD Authorized Rep with mandatory vigilance reporting & FSCAs to Notified Bodies, Competent Authorities and Customers within the EU

Implementing and maintaining the Quality Management System according to the European and International regulations/guidelines; ISO 13485:2016, FDA 21CFR 820, EUMDR 2017/745

Updating (incl. writing of) of SOPs/WIs to ensure the highest compliance to our standards

Quality approver of QMS changes in lieu of the Quality Manager

Maintaining (in view of audit readiness) all QMS documents (& records) in relation to operational & commercial processes (incl. field sales, Customer Service and Order Management etc.)

Ensuring that the Complaint Device Handling is done in a timely and orderly manner

Updating/maintaining the Complaint handling database/SAP searches to aid complaint investigations

Supporting the Quality and Operations Team with the implementation of processes - incl. System Installations

Supporting the Operations Team with the physical distribution of our products (incl. logistics)

Maintaining TEDS - TMS for International (incl. aiding people managers in annual reviews etc.)

Assisting the Quality Manager and Team with the onboarding processes of new hires

Maintaining the highest level of compliance (in the form of training sessions) for the employees

**You are a part of**
The international Quality team for our Image Guided Therapy Devices department. We are a very diverse and dynamic team, located in Zaventem (BE)

**To succeed in this role, you’ll need a customer-first attitude and the following**
- Degree in science or engineering
- Relevant working experience in Quality
- Dynamic, confident, approachable
- Fluent in English, any other language is an advantage

**How we work at Philips**
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home - for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:

- We believe in the importance of impactful collaboration:_ There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
- We embrace flexibility:_ Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
- We want to be at our best:_ The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

**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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

**_
LI-EU_

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