Quality Engineer – MedTech Validation & Impact

ROM Utrecht Region; Utrecht; Hybrid; EUR 65,000 - 95,000; Full time

Job summary

ViCentra is seeking a Quality Engineer to ensure validated, scalable processes for insulin pump technology. You will drive IQ/OQ/PQ validation, create and review documentation, and collaborate with Manufacturing, R&D, Regulatory, and CMOs to strengthen quality controls throughout design, development, and production.

The role emphasizes design transfer, inspection method development, data analysis, and compliance with ISO 13485 and EU MDR in a startup-scale environment, offering significant

Qualifications

• Drive validation activities (IQ/OQ/PQ, TMV) on processes, methods, equipment and specifications, including documentation review and approval
• Bring a quality lens to product and process development, design transfer and technology projects
• Partner with Manufacturing, R&D, Quality, Regulatory, suppliers and CMOs to develop and 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 turn results into clear, defensible decisions
• Keep our work compliant with ISO 13485, EU MDR and QMSR (21 CFR 820), as well as internal procedures
• Contribute to project management, and potentially lead projects within the QE team, keeping deadlines and deliverables on track
• 3 to 5 years of experience in Quality Engineering, preferably within medical devices or another regulated industry
• 3 to 5 years of hands-on process validation experience (IQ/OQ/PQ, TMV)
• Experience with Design Control, cleanroom standards or sterilisation processes (Gamma, EtO), or a start-up or scale-up environment is a strong plus
• Creative freedom
• Supportive teamwork
• Room to lead initiatives
• Direct impact in people’s lives

Responsibilities

• Drive and support validation activities (IQ/OQ/PQ, TMV) on processes, methods, equipment and specifications, including documentation review and approval
• Bring a quality lens to product and process development, design transfer and technology projects
• Partner with Manufacturing, R&D, Quality, Regulatory, suppliers and CMOs to develop and 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 turn results into clear, defensible decisions
• Keep our work compliant with ISO 13485, EU MDR and QMSR (21 CFR 820), as well as internal procedures
• Contribute to project management, and potentially lead projects within the QE team, keeping deadlines and deliverables on track
• 3 to 5 years of experience in Quality Engineering, preferably within medical devices or another regulated industry
• 3 to 5 years of hands-on process validation experience (IQ/OQ/PQ, TMV)
• Experience with Design Control, cleanroom standards or sterilisation processes (Gamma, EtO), or a start-up or scale-up environment is a strong plus
• Creative freedom
• Supportive teamwork
• Room to lead initiatives
• Direct impact in people’s lives

Skills

Quality Engineering

Process Validation

Statistical Techniques

Documentation Review

Change Control

Data Analysis

Attention to Detail

Problem Solving

Collaboration Skills

Project Management

Job description

ViCentra is seeking a Quality Engineer to ensure validated, scalable processes for insulin pump technology. You will drive IQ/OQ/PQ validation, create and review documentation, and collaborate with Manufacturing, R&D, Regulatory, and CMOs to strengthen quality controls throughout design, development, and production.

The role emphasizes design transfer, inspection method development, data analysis, and compliance with ISO 13485 and EU MDR in a startup-scale environment, offering significant