Complaints Analyst & Quality Engineer - Paris
The Complaints Analyst & Quality Engineer position is a key role within the Quality and Regulatory Department of the Medical Business Unit. This role will be based in the Materialise Paris Office and has as its main purpose the proper collection, documentation, assessment of complaints and related CAPA, and supplier quality assurance to drive improvement.
What you will do
- 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 CAPAs, defining action plans for these CAPAs, and making sure the right people are involved.
- 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 up to 3 years of quality, complaint handling, or regulatory experience in a medical device or any other highly regulated industry.
- Excellent (English and French) communication skills and strong networking abilities with internal teams.
- Accurate technical writing skills in English and 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.
Location and type of contract
Working at Materialise
Materialise is a dynamic, international high-tech company, founded in 1990 and headquartered in Belgium, with over 2,300 employees worldwide. Materialise’s mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D printing). Our customers are in diverse industries, such as automotive, aerospace, medical, research, and academia.
As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.