Qualifications & Experience
Complaint Analyst (75%)
- You will evaluate, investigate, and document customer feedback and complaints for our Medical Device products (such as implants, instruments…etc).
- 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 & Notified Bodies (e.g., ANSM, SGS) 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 KPI activities.
- You will be managing complaint related CAPA’s, define action plans for these CAPA’s and make sure the right people are involved.
Quality Assurance (25%)
- As Quality Engineer, you are responsible for general support to our quality management operations. Based on a list of priorities, you will work to meet the requirements of our certifications and enable the quality teams in the business units to do so as well.
- Your responsibilities will include organizing and overseeing our supplier quality auditing program including post-audit corrective and preventive actions and monitoring of the systems used within quality management.
- You will play a central role in managing our Supplier Specification Requirements in compliance with international standards: you will be in close collaboration with Process Engineer teams, allowing the business units to efficiently manage their activities, eventually, you will present the process to external auditors.
- You will support process owners in their quality management tasks
- You report to the Quality Manager
- Bachelor’s degree in quality, Biomedical, Physical, Biological, or Life Sciences. Along with 0 to 3 years of quality, complaint handling, or regulatory experience in a medical device or any other highly regulated industry.
- Excellent (English & French) communication skills and strong in networking with internal teams.
- Accurate technical writing skills in English & French.
- 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.