Senior Validation & Quality Engineer – MedTech CDMO

Vivolta; Eindhoven; Hybrid; EUR 65,000 - 85,000; Full time

Benefits offered by this job

Pension

25+ days off

5 ADV days

Lease-a-bike

Job summary

Vivolta in the Netherlands is seeking a hands-on Quality Engineer to strengthen the Quality team in a regulated CDMO environment. You will lead validation activities, develop test methods, and support SPC and process validation in collaboration with Manufacturing, Engineering and R&D.

The role emphasizes ISO 13485:2016, FDA and EU MDR compliance, QMS maintenance, internal and external audits, CAPA, risk management, and documentation discipline.

Qualifications

• Bachelor’s degree in a technical discipline (see Education).
• Minimum 3 years in Quality Engineering or Validation in medical devices (must).
• Strong knowledge of ISO 13485, ISO14644 and QMS documentation structures.
• Experience with FDA and EU MDR regulatory requirements.

Responsibilities

• Plan, execute, review, and document validation activities for equipment, utilities, cleanroom processes, manufacturing processes, software/tools where applicable, and test methods.
• Support quality management system improvements and maintenance (CAPA, change control, supplier quality).
• Prepare and perform internal audits and support external audits (Notified Body, customers, regulators).
• Conduct risk management activities (FMEA) and root-cause analyses; implement corrective actions.

Skills

Analytical & problem-solving

Fluent English

Education

Bachelor’s degree in Chemical Engineering, Chemistry, Biomedical Engineering, Biology, Medical Biology, Laboratory Research, or related technical discipline

Tools

Statistical tools

Six Sigma Green Belt

Job description

Vivolta in the Netherlands is seeking a hands-on Quality Engineer to strengthen the Quality team in a regulated CDMO environment. You will lead validation activities, develop test methods, and support SPC and process validation in collaboration with Manufacturing, Engineering and R&D.

The role emphasizes ISO 13485:2016, FDA and EU MDR compliance, QMS maintenance, internal and external audits, CAPA, risk management, and documentation discipline.