Medemblik
3 weeks ago
Quality Engineer
Cytiva
Medemblik
3 weeks ago
Quality Engineer
Quality Engineer responsible for maintaining validated state of products, processes, methods and equipment at Cytiva in Medemblik, Netherlands. Requires Master's degree, 3+ years experience, knowledge of ISO 9001 and ISO 13485. On-site position.
On-siteFull-timeEntry LevelISO 9001ISO 13485
Quality Engineer
Quality Engineer responsible for maintaining validated state of products, processes, methods and equipment at Cytiva in Medemblik, Netherlands. Requires Master's degree, 3+ years experience, knowledge of ISO 9001 and ISO 13485. On-site position.
On-siteFull-timeEntry LevelISO 9001
Salary
Not specified
Core Qualifications
Technical (Must-have)
ISO 9001ISO 13485validationProcess flow chartsProcess Control PlansProcess FMEAdata analysis
Soft Skills
analytical mindproblem solving
Preferred Qualifications
Technical (Nice-to-have)
Root Cause analysisQMSValidation processes
Key Responsibilities
- Support/lead ME/PE to implement/maintain Process flow charts, Process Control Plans, Process FMEA, validations.
- Issue or review and approve validation documents related to gamma irradiation and product sterility claims.
- Coordinate validation activities & development of analysis methods with laboratory contractors.
- Support responses to customer questionnaires, certification requests and surveys.
- Serve as Quality Lead in plant wide projects and engage in R&D projects for new product introductions.
Quality EngineerBiotechnologyQuality AssuranceISO 13485ISO 9001ValidationMedemblikOn-site