Hybrid MedTech: Quality Engineer, Process Validation

Kaleido; Utrecht; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

ViCentra in Utrecht, the Netherlands, seeks a Quality Engineer, Process Validation to ensure our insulin pump processes are proven, repeatable and scalable. You will drive IQ/OQ/PQ activities across processes, methods, equipment and specs, collaborating with R&D, Manufacturing, Regulatory, suppliers and CMOs to transfer and scale products.

You will apply statistical methods to validation data, maintain ISO 13485 and EU MDR compliance, and contribute to project management within the QE team,

Qualifications

• Bachelor's degree in Quality, Mechanical or Biomedical Engineering, Health Sciences, or equivalent practical experience.
• 3–5 years of experience in Quality Engineering, preferably in medical devices or another regulated industry.
• 3–5 years of hands-on process validation experience (IQ/OQ/PQ, TMV).
• Solid knowledge of statistical techniques and experience with Minitab or similar data analysis software.
• Deep understanding of quality control principles, quality management systems and risk management.
• Excellent grasp of ISO 13485, EU MDR and QMSR (21 CFR 820).
• Fluent written and spoken English; strong MS Office and IT skills.

Responsibilities

• Drive IQ/OQ/PQ validation activities on processes, methods, equipment and specs.
• Bring a quality lens to product and process development and design transfer.
• Collaborate with Manufacturing, R&D, Quality, Regulatory, suppliers and CMOs to improve quality controls and documentation.
• Develop and implement inspection processes and test methods.
• Support Change Control for design, development and manufacturing changes.
• Apply statistical techniques to analyse validation data and inform decisions.
• Maintain compliance with ISO 13485, EU MDR and QMSR (21 CFR 820).
• Contribute to project management and potentially lead QE projects.

Skills

Quality engineering

Process validation

Statistical analysis

Quality management

ISO/Regulatory knowledge

English proficiency

Collaboration

Detail oriented

Education

Bachelor's degree in Quality, Mechanical or Biomedical Engineering, Health Sciences, or equivalent

Tools

Minitab

Microsoft Office

Job description

ViCentra in Utrecht, the Netherlands, seeks a Quality Engineer, Process Validation to ensure our insulin pump processes are proven, repeatable and scalable. You will drive IQ/OQ/PQ activities across processes, methods, equipment and specs, collaborating with R&D, Manufacturing, Regulatory, suppliers and CMOs to transfer and scale products.

You will apply statistical methods to validation data, maintain ISO 13485 and EU MDR compliance, and contribute to project management within the QE team,