MedTech Quality Engineer – Cross-Functional Impact

Barrington James; Amsterdam; On-site; EUR 65,000 - 95,000; Full time

Job summary

Barrington James is seeking experienced Quality Engineers for Netherlands-based medical-device projects. The role focuses on quality across development and manufacturing, with close collaboration to R&D, Manufacturing, Regulatory and Operations to sustain high product quality in regulated environments.

Ideal candidates will have a degree in a relevant technical field, experience in regulated healthcare manufacturing, and strong root-cause analysis and CAPA capabilities.

Qualifications

• Degree or equivalent in Engineering, Quality, Life Sciences or related field.
• Experience in medical devices, diagnostics, pharmaceuticals or other highly regulated manufacturing environment.
• Experience with CAPA, non-conformance investigations and root-cause analysis.
• Familiarity with ISO 13485 and medical-device quality systems.
• Experience with risk management, change control and/or validation.
• Strong analytical and problem-solving capabilities.
• Confident communicator with technical and non-technical stakeholders.

Responsibilities

• Support and maintain quality processes across medical-device development and manufacturing activities.
• Lead or support investigations into non-conformances, complaints and quality issues.
• Perform root-cause analysis and develop effective corrective and preventive actions.
• Support CAPA, change control and deviation processes.
• Participate in internal and supplier audits.
• Monitor quality performance and identify opportunities for process improvement.
• Support validation and qualification activities.
• Contribute to risk-management activities and product/process risk assessments.
• Work closely with R&D and Manufacturing Engineering on design and process changes.
• Prepare and maintain quality documentation in accordance with the applicable QMS.
• Support compliance with relevant medical-device standards and regulatory requirements.

Skills

CAPA investigations

Non-conformance investigations

Root-cause analysis

Quality systems (ISO 13485)

Risk management

Change control

Validation

Audits (internal & supplier)

Stakeholder communication

English proficiency

Education

Degree in Engineering/Quality/Life Sciences

Job description

Barrington James is seeking experienced Quality Engineers for Netherlands-based medical-device projects. The role focuses on quality across development and manufacturing, with close collaboration to R&D, Manufacturing, Regulatory and Operations to sustain high product quality in regulated environments.

Ideal candidates will have a degree in a relevant technical field, experience in regulated healthcare manufacturing, and strong root-cause analysis and CAPA capabilities.