(Senior) Complaint Investigator (m/f/d) Medical Technology
vor 6 Tg.

Job Description

In this role, you have the opportunity to

support the investigation of product complaints, including making reportability evaluations for competent authority reporting and quality monitoring potentially leading to corrective actions and product improvements.

Q&R activity involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.

You are responsible for

  • The investigation of product malfunctions, product design and / or labeling problems, customer application problems as well as customer dissatisfaction issues
  • Assuring compliance with applicable regulatory requirements, including timely investigations and timely reporting as required by national device regulations
  • Analyze product quality, safety, and reliability issues and escalate as warranted to management and other functions
  • Initiate and facilitate corrective or preventative actions as needed
  • Drive customer and regulatory communications for current products
  • Participate in cross-functional team initiatives related to product issues and support quality and product teams
  • Supporting of medical incident reporting to National Competent Authorities
  • You are part of

    our complaint handling team which investigates product complaints and interacts with colleagues on Key Markets / Field Service Engineers (contacting customer), Product Support Engineers (product application), R&D (product design, risk management), Marketing (Instructions for Use), Repair Bench (testing of returned products).

    The investigator decides about reportability of incidents with patients / users if necessary discusses with colleagues and Safety Officer.

    Input for reports to Competent Authorities is communicated to the Adverse Event Coordinators.

    In case of product problems and the necessity of a CAPA request there is a close cooperation with the CAPA owner (Corrective And Preventive Action) and the HHE owner (Health Hazard Evaluation).

    Tasks are beside the complaint investigation and trending the participation in Cross Functional Teams and Product Trainings.

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

  • Education in a Technical or Clinical discipline or equivalent professional qualification and experience
  • Experience in the quality, compliance or regulatory area, preferably in a healthcare environment
  • Experience in a regulated industry as well as in an international environment
  • Knowledge of quality tools / techniques and analysis methods
  • Demonstrated effectiveness in independently investigating problems and moving them towards resolution
  • Organized and structured work approach
  • High reliability and quality focus
  • High engagement, motivation and flexibility
  • Business fluent in English, good German skills preferred
  • In return, we offer you

    a high level of interaction with most other disciplines of the company. If the ability to learn rules and employ systematic approach and techniques is given, the position enables the employee to do multi-

    tasking while keeping the overview, learn a lot about regulations, products, medical device application and medical device environment.

    Beyond the regular complaint handling business each team member shall have specific tasks which are employed both internally and in contact with other departments.

    Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our Health Systems division, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).

    However, by taking pride in all you do and inspiring others around you to prioritize Quality above all else, you’ll be contributing to a higher Quality of life for billions and helping Philips deliver innovation that matters.

    Philips encourages people with a disability to apply. Part time possible.

    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.

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