Publication date
Location
Mechelen
Country
Belgium
Workplace type
Hybrid
Travel percentage
0%
Department
Quality, Regulatory and Clinical Affairs
Function type
Full-time
Contract type
Employee
Experience required
- Preferably at least 2 years of relevant experience in a quality function within the healthcare industry.
- Experience in an IVD – Medical Diagnostics manufacturing environment is a plus.
Education
- Master’s degree in engineering or life sciences (biomedical, chemical, pharma…) or equivalent through experience/training.…).
The QA Engineer I – Quality Assurance On-Market Product Support (QA OMPS) supports on market product support activities from the quality perspective.
Accountabilities
- QA activities for OMPS activities related to: assay (type 1), platform hardware, platform software, incoming materials and CMO activities. This includes NCRs, CRs, CAPAs and Complaints;
- Support design transfer of assays to operations from QA perspective;
- Support platform hardware lifecycle projects from QA perspective;
- Support Idylla software eco-sphere projects from QA perspective;
- Participate in continuous improvement of existing processes and procedures related to Biocartis’ customer facing processes;
- Participate in audits performed by external parties;
- Quality Oversight on Distributor Management & Distributor Monitoring Performance.
Profile requirements
- Master’s degree in engineering or life sciences (biomedical, chemical, pharma…) or equivalent through experience/training.…).
- Preferably at least 2 years of relevant experience in a quality function within the healthcare industry;
- Experience in an IVD – Medical Diagnostics manufacturing environment is a plus;
- Experience in participating in deviation investigations, determining root cause, and developing corrective action plans;
- Experience with Customer Complaints is a plus;
- Customer focused;
- Very accurately and have an eye for detail;
- Good organization and prioritization skills, and able to adapt to changing priorities;
- Good analytical and conceptual thinking skills with the ability to solve key problems;
- Good communicator, verbally and in writing;
- Able to work in team and influence others;
- Electronic Quality Management System (e.g., Scilife);
- Microsoft Office (Word, Excel, Outlook, Powerpoint);
- Business Enterprise Resource Planning ERP (e.g.: SAP, D365);
- Languages : fluency in Dutch and English.
Our offering
We offer you a truly exciting job in a fast growing international and innovative environment where you can work with top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team. You will have freedom to shape your work and shape your job where you deem it necessary: we value your input.
We offer a very market-competitive compensation package which includes a Flexible Income Plan.
We work hybrid which means 3 days in the office and 2 days work from home.