Qualifications & Experience
The Complaints Analyst position is a key role within the Quality and Regulatory Department of the Medical Business Unit at our HQ in Leuven, Belgium. This role will have as main purpose the proper collection, documentation, assessment of complaints and other post-market information, to drive improvement.
- You will evaluate, investigate and document customer feedback and complaints for our Medical Device products (such as instruments, implants and software).
- You will collaborate with internal stakeholders from all global Materialise sites to perform root cause analysis on reported problems.
- Based on investigation results, you will work with internal teams (such as Operations, R&D) to define improvements necessary for process and product quality.
- You will communicate with Competent Authorities (e.g. FAGG, FDA) on adverse events, incidents, and product recalls, as required by regulations.
- Communication with customers and our commercial partners is important to collect valuable information, and to assist with providing a solution for their complaints.
- You will extract important information (trends, complaint data, etc.) from the different quality systems and process this information as part of Post-Market Surveillance activities.
- Bachelor degree in Quality, Biomedical, Physical, Biological, or Life Sciences,… along with 0 to 4 years of quality, complaint handling, or regulatory experience in a medical device or any other highly regulated industry.
- Excellent (English) communication skills and strong in networking with internal teams.
- Accurate technical writing skills in English.
- Good analytical skills, meticulous approach with a high level of attention to detail.
- Passionate about quality assurance and customer satisfaction.
- Knowledge of medical device standards and regulations (such as ISO 13485, 21 CFR820 and EU MDD/MDR) is a plus.