In this role, you have the opportunity to

　　The primary purpose of this position is to function in the role of Specialist- I QA/QE in Q&R functiontoSupport and facilitate Quality Engineering activities in MR software projects/programs..This role will support the realization and delivery of various products, key business improvement programs, and work with cross functional teams from various geographical sites fromEurope .The key challenge is tocontribute to the success of Philips Health Systems by managing Q&R challenges on both process and product level. The key to succeed is to utilize all your technical and personal skills in the dynamic, multi-disciplinary

　　You are responsible for

　　The Quality & Regulatory group is responsible for:

　　Quality assurance and Quality Engineering aspects of product development

　　Assessment of the quality performances and compliance of the organization

　　The relation with external regulatory bodies

　　Supporting the continuous improvement of processes and the initiation and maintenance of Quality Management System (QMS), while assuring regulatory compliance of this QMS.

　　Responsibilities:

　　Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design

　　Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs

　　Support and advise the organization in corrective and preventive actions

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

　　Provides effective oversight of the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle

　　Can lead quality related problem solving for software

　　Use post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers, or design teams) and initiate field actions when required

　　Act as a single point of contact (person assigned to project team) responsible to ensure that software design quality relatedrequirements/criteriaare completed and meet SW Quality standards for every milestone

　　Develop strong working relationships with program teams to establish standard documentation procedures. As needed engage with programs with project management expertise to support/ensure successful delivery by a combination of coaching, training, and auditing capabilities

　　Analyze current workflows and review existing documentation, recommend, and implement improvements to current processes and documentation and assure compliance with standards

　　Participate/Drive in project meetings to provide guidance and support related to process and project documentation

　　Prepare and conduct quality assurance product reviews and prepare projects teams ready for audits according to the audit plan

　　Key performance indicators

　　•CoNQ

　　FCR/DEFOA/FCO

　　Ratings & Reviews/ NPS

　　of critical findings in software auditscritical findings in design related processesTo succeed in this role, you should have the following skills and experience

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

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

　　Knowledge of (software) processes and procedures

　　Qualified Auditor of Quality Systems( Preferable)

　　Good skills in reporting, both in writing and oral

　　Fluent speaker and writer in English

　　Project management knowledge and skills.

　　Sound knowledge of the basic functionality of our products

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

　　Experience in using problem solving tools

　　Experience in working with legal documents

　　Knowledge of external regulations and standards relevant for our products

　　Ability to translate legal requirementsin toprocedures and instructions

　　In return, we offer you

　　Here atPhilipsWE ARE Working Together for a Better Tomorrow:

　　Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people.Philipsproducts lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.

　　Enjoy endless opportunities tolearn, anddevelop 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. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare and allow you to create your own legacy.  Thanks to our employees, we are at the forefront of the Healthcare industry 

　　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 2.5 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.