Quality Manager

Quality Manager (Contract)

Location: HTC, Eindhoven

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

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.

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:

General Quality

• Promoting Quality awareness throughout the organization and supporting local leaders in fostering Quality culture

• Partnering with local organization(s) to ensure compliance to all relevant regulations and internal Philips requirements

• Promoting continuous improvement through involvement in process excellence activities

• Representing Quality in business and commercial projects

Post-Market Surveillance

• Stimulating the customer feedback process & ensuring a complaint handling process is executed

• Ensuring execution of non-product customer feedbacks and third-party products complaints handling processes

• Ensuring timely execution of Corrections & Removals (C&R) strategies as applicable for the local organization

• Ensuring escalations to the relevant functional partners

• Reviewing Quality communication when necessary

• Provides Advisory and Support to Service Record reviewers for content and on Good Documentation Practice

CA Account Management

• Act as a liason between CA's and Philips, seading CA meetings and strategic discussions with CA interacting with Philips ARs & PRRCs,

• Interacts with Philips ARs & PRRCs for C&R and Incidents handling relevant to Zone

• Revises answers to CAs questions for C&Rs and MIRs of serious injuries/deaths classification

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

Education and Experience

• University degree level education or equivalent

• 4 years experience in the Medical Device or Equivalent Quality environment

• Fluent in English, verbal and written

CA Account Management:

• PMS Regulatory Background (EU MDD/MDR and related documents)

• Experience in Vigilance and Safety Reporting management and consequences

• Concept of Risk Management, Business Impact and ISO13485/FDA’s 21 CFR

• Basic product and modality portfolio knowledge"

Competencies

• Working knowledge of relevant international ISO Standards (ISO 13485, ISO 9001 and, as preferred, ISO 14971)

• Internal audit capabilities (ISO 9001 and ISO 13485)

• Experience in Continuous Improvement methodologies such as Process Excellence Greenbelt, Lean, Kaizen, Problem Solving, Daily Management

• Demonstrated ability to align business needs, quality compliance and regulatory requirements

• Problem solving skills

• Communication skills

• People management and teamwork ability

• Role modeling in working in a matrix

CA Account Management:

• Strategic thinking abilities, negotiating & influencing skills

• Skills in Dealing with ambiguity / decision making / managing conflicts

• High communicating skills and ability to building trusting relationship

• High focus on Customer and patient needs"

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.