Quality Engineer

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

We are engaging with medical-device organisations in the Netherlands that are strengthening their Quality Engineering teams and are interested in speaking with experienced Quality Engineers from regulated product-development and manufacturing environments.

This is an opportunity for a quality professional who wants to work closely with Engineering, Manufacturing, Regulatory and Operations teams while helping maintain and improve the quality of products used in demanding healthcare applications.

Key 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.

What We're Looking For

• Degree or equivalent qualification in Engineering, Quality, Life Sciences or a related technical discipline.
• Experience within medical devices, diagnostics, pharmaceuticals or another highly regulated manufacturing environment.
• Practical experience with CAPA, non-conformance investigations and root-cause analysis.
• Familiarity with ISO 13485 and medical-device quality systems.
• Experience working with risk management, change control and/or validation.
• Strong analytical and problem-solving capability.
• Confident communicator who can work effectively with technical and non-technical stakeholders.
• Professional working proficiency in English; Dutch would be beneficial for some opportunities.

The Environment

The organisations we are speaking with operate within technically demanding and highly regulated MedTech environments, with opportunities to work across product development, manufacturing and quality improvement.

These opportunities may suit Quality Engineers looking to broaden their responsibilities, move into a more international environment or take the next step within the medical-device sector.

Interested? We are currently building a pipeline of Quality Engineering talent for current and upcoming opportunities across the Netherlands. If you have relevant medical-device experience, we would be interested in a confidential conversation about the market and potential opportunities.