Job Description Summary

The incumbent will work as Complaint Manager (m/f/i) for medical products manufactured in Heidelberg on the complaint resolution, root cause identification and improvement activities.

We are open for applications in full-time and part-time (min. 50%).

Job Description

The tasks and responsibilities in complaint management are

• Leading the complaints process for the Plant

• Performing complaint investigations and drive root cause analyses with respective stakeholders

• Defining relevant corrections and improvement actions based on identified root causes

• If applicable, performing required escalation steps (e.g. material review board, situational analysis, etc.)

• Driving compliance to complaint quality metrics and targets for complaint management

• Presenting complaint data, trends and statistics to relevant stakeholders

• Running the complaint boards

• Being the subject matter expert and to-go person for Complaint Management

Other tasks and responsibilities include:

• Document management which comprises reviewing, overhauling and improving controlled documents in the area of responsibility

• CAPA management (corrective and preventive actions) including implementing relevant CAPA in the area of responsibility

• Supporting external audits from notified bodies and customers (e.g. audit preparation activities, handling information requests and preparing materials/documents for the audits, preparing CAPA plans and conducting follow ups, etc.)

About You

You have a university degree in food technology, process engineering, biotechnology or a related field of study and at least 3 years of professional experience in the food processing, pharmaceutical or chemical industry, ideally in the area of complaint management or improvement management.

Further requirements are:

• Good knowledge of GMP, IVDR or MDR

• Good understanding of root cause analysis process and statistical tools

• Understanding of quality systems regulations and regulated environments

• Good Knowledge of ISO:13485:2016

• Basic Lean Six-Sigma skills

• Very good knowledge of the common Microsoft software applications (e.g. Excel, Word, Power Point) and knowledge of SAP

• Ability to prepare and present data and their presentation and documentation

• Fluency in German and English is a must

Our Offer

A professional challenge in a highly motivated team, a global environment and with long-term perspectives. A familiar working atmosphere in an innovative environment where your opinion matters. Diversity characterizes our corporate culture and we are convinced that it makes us a stronger team. We value each person as an individual with their abilities and needs. In this sense, we welcome applicants who wish to work part-time, people with severe disabilities and applicants of any gender.

Primary Work Location

DEU Heidelberg - Tullastrasse

Additional Locations

Work Shift