MedTech Quality Engineer: Process Validation

ViCentra B.V.; De Meern; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

ViCentra is seeking a Quality Engineer, Process Validation, to ensure validated, repeatable processes behind insulin pump technology and to scale them across production. You’ll collaborate with R&D, Manufacturing, Regulatory, suppliers, and CMOs to transfer from development to production with rigor and care.

You will drive IQ/OQ/PQ and TMV validation, apply statistics, and ensure compliance with ISO 13485, EU MDR, and QMSR while contributing to the QE team’s project delivery and quality culture.

Qualifications

• 3 to 5 years of experience in Quality Engineering in a regulated environment.
• 3 to 5 years of hands-on process validation (IQ/OQ/PQ, TMV).
• Solid knowledge of statistical techniques and data analysis.
• Strong understanding of ISO 13485, EU MDR and QMSR (21 CFR 820).
• Fluent written and spoken English; Dutch is not required.

Responsibilities

• Drive validation activities (IQ/OQ/PQ, TMV) on processes, methods, equipment and specifications.
• 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 improve 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 support decision making.
• Maintain compliance with ISO 13485, EU MDR, QMSR and internal procedures.
• Lead projects within the QE team and manage deadlines.

Skills

Quality Engineering

Process Validation

IQ/OQ/PQ

TMV

Education

Bachelor's in Quality/Mechanical/Biomedical Eng

Tools

Minitab

MS Office

Job description

ViCentra is seeking a Quality Engineer, Process Validation, to ensure validated, repeatable processes behind insulin pump technology and to scale them across production. You’ll collaborate with R&D, Manufacturing, Regulatory, suppliers, and CMOs to transfer from development to production with rigor and care.

You will drive IQ/OQ/PQ and TMV validation, apply statistics, and ensure compliance with ISO 13485, EU MDR, and QMSR while contributing to the QE team’s project delivery and quality culture.