Functietitel: Quality Engineer Software Arbeitsort: Eindhoven

Functieomschrijving:
USG ENGINEERING in cooperation with PHILIPS is searching for you! Responsibilities: ¿Support and facilitate the department in enabling and assuring that medical regulated products are developed and produced in compliance with requirements from applicable standards (process focus); ¿Embed Quality & Regulatory requirements in the design and build processes for End to End software development (connected measuring devices, apps on smartphones, storage in Philips cloud, and data analytics/visualization/insights generation); ¿Create the (project) quality plan and make sure it is being executed; ¿Help to apply the QMS processes and procedures in the project; ¿Support in applying requirements of applicable standards (ISO13485, ISO14971, IEC62304, IEC60601); ¿Are responsible for the product risk management plan and V&V-plan; ¿Are responsible for requirements traceability, and monitor upon completion; ¿Assist in experimental setup (compliance to relevant standards); ¿Prepare milestone reviews by collecting the status of all deliverables; ¿Ensure proper approval of deliverables; ¿Participate in risk assessments; ¿Participate in review meetings; ¿Review and approve Corrective Actions and Preventive Actions (CAPA) ¿Review and approve product change controls for quality and regulatory compliance impact and determine requirements for implementation; Technical requirements: We are looking for someone with a¿ ¿Master¿s degree with 2+ years of QA experience, Bachelor degree in a technical field with 4+ years¿ experience in (networked) medical regulated product development; ¿Preferably you are a Certified Quality Engineer (ASQ); ¿Relevant work experience in product software development with demonstrable focus on quality and acting as a quality engineer; ¿Excellent understanding of medical device development and in driving quality and regulatory challenges regarding US and EU medical device regulations (i.e., 21 CFR 820, MDD); ¿Proven track record with development methodologies like Agile/Scrum/V-Model; ¿Experience with working in 10+ person multidisciplinary teams; This role will appeal to you if you¿ ¿Enjoy working in cross-functional teams; ¿Are curious, open and feel at home in an international environment; ¿Have an affinity with innovative development projects and feel comfortable with relatively vague requirements; Soft skills: ¿Excellent communication skills (fluent in English, preferably also in Dutch); ¿Strong analytical, conceptual and creative thinking skills. A problem solving and pragmatic attitude; ¿Determination to achieve excellent results; ¿Capable of working in a fast pace environment; ¿Finds better ways; ¿Inspires commitment; ¿Develops self and others; ¿Organization and planning; ¿Architectural style thinking; What do we offer: We offer the opportunity to play a leading role in achieving Philips¿ ambitions with digital connected products and to truly contribute to the way our innovations improve the health and well-being of our customers. You will work in close cooperation with global teams across Philips, playing a key role in driving the transition process that will turn Philips into a Digital Systems company. We invite you to be part of a challenging, innovative environment with great opportunities for personal development. ¿A (permanent) contract with a great variety of projects; ¿An attractive set of secondary working conditions; ¿A place for interesting work with our own training center and knowledge networks; ¿A place to develop yourself and broaden or deepen your knowledge; ¿The opportunity to work on the latest developments in your field; ¿Access to prestigious organizations in different sectors; Application process

Uren per week: 40

Werkgever Naam: USG Professionals GmbH

Werkgever adres:
Aachener-und-Münchener-Allee 9, D-52074 Aachen, Deutschland

Vorm van contact: Rolf Call

Werkgever telefoonnummer: +49 89 56827111

Werkgever faxnummer: +49 241 23102

Job korte beschrijving: Elektrotechnisch ingenieurs

Land: Nederland

Regio: Noord-Brabant

Contractduur: Vast

Contract type: Voltijds

Verplicht onderwijs: Niet gespecificeerd

Ervaring: Vereist

Bron van jobaanbieding:
BA, Openbare diensten voor arbeidsvoorziening, Duitsland

Hoe toe te passen: Overig - zie vrije tekst

Salaris munt: EUR

Loontijdvak: Per maand

Salaris belastingen: Bruto