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Quality Specialist

Geplaatst 23 mrt. 2024
Werkervaring
5 tot 7 jaar
Full-time / part-time
Full-time
Soort opleiding
Taalvereiste
Engels (Vloeiend)

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Job Description

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

  • Promoting and communicating the Quality Policy and Quality Culture throughout the EPD Solutions organization
  • Ensure compliance of the Quality Management System, in accordance with applicable worldwide regulations and standards (FDA/ISO) and Philips policies
  • Manage and/or support, as the Quality Business Partner, (strategic) Quality Improvement projects and transition programs
  • Management of the Quality responsibilities of the Non-Product System Software process
  • Supporting the quality Management Review process, maintaining metrics and KPIs for the organization
  • Work closely with product development engineering, clinical, marketing, regulatory, and other business partners to assure appropriate quality requirements are defined for the specific device application and target patient population
  • Validates key design inputs and support compliance assessments of the DHF and other program files to ensure quality and regulatory requirements are achieved and ensuring DHF completeness
  • Identify SOP and WI updates to be performed and manage Change Requests in conjunction with the business and Global Quality teams.
  • Maintain Audit readiness and support both internal and external audits, as needed
  • Facilitate and assist in CAPA execution, including root cause investigations, as CAPA owner or team member

You are a part of

EPD Solutions is as part of the Image Guided Therapy (IGT) cluster. This venture, with ambitious plans for growth, developing a disruptive technology, which will improve the efficiency and efficacy of life-saving cardiac ablation procedures treating among others atrial fibrillation. EPD’s technology has the potential to address the key unmet need of real-time therapy assessment, which is one of the more significant limitations of the current standard of care. We aim to help to improve outcomes for millions of people and help maintain the rapidly rising cost of managing the disease.

To succeed in this role, you’ll need a customer-first attitude and the following

  • 5+ years of demonstrated ability in a regulated environment in quality systems, manufacturing, product development, regulatory compliance, and/or quality engineering in the medical industry.
  • Extensive knowledge about quality affairs, and a thorough understanding of quality principles and practices; balancing regulatory compliance with business objectives using a risk-based approach.
  • Effective at making plans, decisions, and working in a dynamic and fast paced environment where priorities can change, and interruptions occur on a regular basis.
  • Must have direct experience/knowledge of most regulations, such as: ISO 13485/14971, FDA Regulations (21CFR (820, 803, 806, etc.)), CMDR, JPAL, Medical Devices Directive (93/42/EEC, 98/79/EC), EU Medical Device Regulation (2017/745), EN 60601-1-6, IEC 62304, and EN IEC 62366.
  • Skilled in Design and Development processes, preferably knowledge of Philips Product Development Lifecycle Management (PDLM)
  • Demonstrates excellent team collaborative skills and customer focus mindset
  • Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
  • English proficiency oral and written
  • Excellent communications and analytical skills - demonstrated ability to trouble-shoot complex process/system issues
  • Knowledge of medical (Electrophysiology) terminology preferred

Philips Domestic Appliances purpose is simple yet powerful: helping people to turn their houses into homes. Through meaningful innovation, we improve the lives of people, helping them to lead healthier and happier lives every day.
Our goal is for you to grow every day, and to support you to become the very best version of yourself.

FMCG
Amsterdam
Actief in 100 landen
7.000 medewerkers
50% mannen - 50% vrouwen
Gemiddeld 35 jaar oud