In this role, you will have the opportunity to:
- The Quality Engineer Support/lead ME/PE to implement/maintain, as a team member, Process flow charts, Process Control Plans, Process FMEA, validations.
- The Quality engineer is responsible for issuing or reviewing and approving validation documents related to gamma irradiation and product sterility claims
- Coordinate validation activities & development of analysis methods with laboratory contractors
- The Quality Engineer Support responses to customer questionnaires, certification requests and surveys; prepare and maintain/update standard responses/data for use by Customer Service
- The Quality Engineer is the Quality Lead in plant wide projects and will be closely engaged in R&D projects towards introduction of new products as quality lead.
The essential requirements of the job include:
- Degree: Master in a scientific field, preferable in Lifesciences (bio, biomedical, chemical, pharma,โฆ)
- Experience: 3+ years
- Language: English (written & spoken), Dutch
- Uses analytical mind and data analysis to creatively and pragmatically solve problems, comes up with solutions
- Knowledge of quality standards ISO 9001 and ISO 13485
It would be a plus if you also possess previous experience in:
- Root Cause analysis
- QMS
- Validation processes
