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In this role, you have the opportunity to

Perform a wide variety of activities pertaining to compliance with applicable regulatory requirements, quality management system (QMS) maintenance, improvement and harmonization, and quality control and assurance.

You are responsible for

• Verification of execution of processes and their deliverables in product creation and subcontracting projects and report the findings to upper management

• Review and Approval of designated project documentation in product creation projects

• Advice to product creation projects concerning the definition and implementation of quality assurance activities

• Advise upper management with respect to release for delivery of products

• Support and represent Q&R discipline in Design Reviews, Hazard Analysis brainstorms, Health Risk Assessments

• Initiate, stimulate, and support the implementation of process improvements

• Execution of audits in all business processes and report the findings to upper management

• Support and advise the organization in corrective and preventive actions

• Participate in the maintenance, improvement and deployment of the Quality Management System

• Translates regulations and standards and bring them to consolidation in the organization and the Quality Management System

• Represent the approbation officer in projects and support in the activities to acquire product licenses and approvals

• Participation in and verification off changes to DMR and release orders where Q&R involvement is needed

• Produces and completes SW Quality Engineering documents under direct supervision

• Responsible for performing timely, detailed SW Quality engineering tasks like: assessing software designs and reviewing test and other performance data, analyses market feedback, completing or assisting with in root cause analysis and SW Quality problem solving

• May also provide other SW quality engineering support, including assisting organizational units in addressing SW Quality engineering deficiencies

You are a part of

EDI (Enterprise Diagnostic Informatics) Q&R Organization. Our mission to improve the lives of 3 billion people per year by 2030. Every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. We enable our employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs. Our research and business provides unique opportunities to develop cutting-edge clinical solutions and deliver meaningful solutions in the healthcare space.

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

• Bachelor or Master degree in relevant knowledge domain, e.g.: Computer Science , electronics, Electrical or information technology

• Knowledge of relevant external standards for Quality Management Systems for medical devices (e.g. ISO13485, ISO 14971, MDD, 21 CFR Parts 803,806, and 820, ISO 9001)

• Knowledge of (software) processes and procedures

• Good skills in reporting, both in writing and oral

• Fluent speaker and writer in English

• Project management knowledge and skills.

• Knowledge of product creation and (software) development methods & tools

• Ability to translate legal/Regulatory requirements in to procedures and instructions

• Qualified Auditor of Quality Systems - preferable

• Experience in using problem solving tools - advantage

In return, we offer you

Endless opportunities to learn and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already.

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 improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

#LI-EU

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there,you can also learn about our recruitment process , or find answers to some of the frequently asked questions .