Philips Quality Specialist (m/w) for TOMTEC in Munich in Unterschleissheim, Germany

Your role

  • Technical or medical educational Background

  • Work experience (QM in medical device field)

  • Auditor

  • Experience in supplier management

  • Experience in complaint files (21CFR820)

  • Experience in CAPA handling (root cause analysis)

  • Willing and able to make decisions

  • Strong assertiveness

  • Strong communication and argumentation skill

  • Fluent in German and English

Your Profile

  • Responsible for implementation of regulatory requirements into the QMS and maintain QMS

  • Responsible for complaint files

  • Responsible for handling of supplier / outsourced process service Provider

  • Review / document trainings (training tool)

  • Review and implement QMS related requirements of partner / customer into the QMS

  • CAPA planning / monitoring / effectivity check

  • Participate in audits

  • Perform internal / external Audits

  • Perform Analysis

  • Perform process Validation

  • Perform change Management

  • Perform trainings regarding QM issues

TOMTEC IMAGING SYSTEMS GMBH, with headquarter located in Munich / Germany, is a worldwide leader for medical image software solutions. Specialized in cardiology it offers state-of-the-art solutions for clinical customers and industry partners.

The products encompass a wide range of 2D and 3D/4D technology for visualization, automated analysis, quantification, reporting and image management. TOMTEC products are available for adult and pediatric cardiology, obstetrics, gynecology, radiology and vascular diagnostics. Moreover, TOMTEC offers a sustainable full-service component in sales and an education program with best-practice sharing among professionals.

The company claim "Excellence in Digital Healthcare" represents striving for excellent image and analysis quality, ease-of-use, reproducibility of automated measurements and an all-around service- and education offering.The company maintains close working relationships with many leading universities and research institutes around the world.

In July 2017, TOMTEC became a part of the Philips Ultrasound Business group. However, TOMTEC is continuing its vendor independent product portfolio.

To support our Quality Team in UnterschleiƟheim we are currently looking for a Quality Specialist (m/w) with the following profile:

Your responsibilities

  • Responsible for implementation of regulatory requirements into the QMS and maintain QMS

  • Responsible for complaint files

  • Responsible for handling of supplier / outsourced process service Provider

  • Review / document trainings (training tool)

  • Review and implement QMS related requirements of partner / customer into the QMS

  • CAPA planning / monitoring / effectivity check

  • Participate in audits

  • Perform internal / external Audits

  • Perform Analysis

  • Perform process Validation

  • Perform change Management

  • Perform trainings regarding QM issues

Your background

  • Technical or medical educational Background

  • Several years of work experience (preferred: QM in medical device field)

  • Auditor

  • Experience in supplier management

  • Experience in complaint files (21CFR820)

  • Experience in CAPA handling (root cause analysis)

  • Willing and able to make decisions

  • Strong assertiveness

  • Strong communication and argumentation skill

  • Fluent in German and English

Our offer

  • Working in a motivated team

  • Versatile, challenging tasks in a growing company in an international environment

  • An innovative environment with the chance to evolve

  • An excellent working atmosphere with flat hierarchies and short decision makings

  • An attractive and dynamic salary package, excellent employee benefits and supplementary pension

  • Flexible trust-based working hours, massages, sports courses, regular team events and much more

Please apply online via our website with your full application.