Quality Engineer

Position Summary  The Quality Engineer will maintain the validated state of products, processes, methods, and equipment, handle deviations, and serve as the quality lead for plant-wide and R&D projects.

Key Responsibilities   Maintain the validated state of products, processes, methods, and equipment.
Handle deviations of any kind and perform root cause analysis.
Serve as quality lead for plant-wide projects and closely engage in R&D projects towards introduction of new products.
Support and lead ME/PE to implement and maintain Process Flow Charts, Process Control Plans, Process FMEA, and validations.
Issue or review and approve validation documents related to gamma irradiation and product sterility claims.
Coordinate validation activities and development of analysis methods with laboratory contractors.
Respond to customer questionnaires, certification requests, and surveys; prepare and maintain standard responses/data for use by Customer Service.
Qualifications   Master’s degree in a scientific field (Life Sciences, biomedical, chemical, pharmaceutical, etc.).
Minimum 3 years of relevant experience.
Proficiency in English (written & spoken) and Dutch.
Analytical mind and data analysis skills to creatively solve problems.
Knowledge of ISO 9001 and ISO 13485 quality standards.
Preferred experience in root cause analysis, QMS, and validation processes.
Location  Cytiva, Medemblik, Netherlands. Position is on-site.

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