Complaints Analyst & Quality Engineer - Paris
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Materialise is a dynamic, high-tech company headquartered in Belgium, with offices worldwide. Founded in 1990, today we have over 2,100 employees around the globe. Materialise’s mission is to innovate for a better and healthier world through our software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D printing). To achieve this goal, we collaborate with businesses in diverse industries such as automotive, aerospace, healthcare, 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.
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 Materialise Paris Office and has as main purpose the proper collection, documentation, assessment of complaints and related CAPA, and supplier quality assurance, to drive improvement.
Qualifications & Experience
Responsibilities
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
Requirements
- 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.
We offer an inspiring and challenging job with growth potential in an innovative market. You will be part of a dedicated team within a dynamic company that highly values openness, trust and team spirit.
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Having a healthy work-life balance
When creating a better and healthier world, a good place to start is with yourself. That’s why we encourage our employees to stay fit both physically and mentally by offering sports workshops and flexible hours with the possibility of working remotely.
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Personal growth and career opportunities
Materialise invests in people and want to see them grow in a career that fits them best. We offer personal training to every employee, so they can access every available career opportunity.
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Team building
It’s also important to enjoy working at Materialise. With initiatives such as memorable team building activities, lively after-work drinks and team lunches, we’re building a work environment in which our employees feel good.
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Innovation is key
Innovation isn’t an empty word at Materialise. We create and deliver high-tech solutions in additive manufacturing. Innovation and leadership by our employees is both encouraged and rewarded.