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 .
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 .