Quality Systems Engineer - Medical Devices & CAPA

Philips International; Best; On-site; EUR 48,000 - 81,000; Full time

Job summary

Philips is seeking a Process Quality Engineer to elevate manufacturing quality in Best, NL. You will analyze defects, manage Non-Conformances and Quality Notifications, and drive CAPA actions to prevent recurrence while supporting PFMEA assessments and design transfers.

The role emphasizes data-driven quality improvements, supplier collaboration, and regulatory compliance. Office-based in Best with on-site work required; occasional travel may occur.

Qualifications

• 2+ years’ experience in FDA regulated (ISO 13485) medical device quality/manufacturing environments.
• Strong experience in CAPA actions, non-conformances, root cause analysis and implementing solutions to prevent recurrence.
• Experience with quality analytics, risk assessment and reporting across product lifecycle.

Responsibilities

• Analyze defects to disposition non-conformances and manage NCs and QNs.
• Lead CAPA actions to prevent recurrence and drive continuous improvement.
• Assess PFMEA impact and controls related to design changes.
• Support operations performance monitoring, risk assessment, reporting, improvement and development, and QA programs.
• Coordinate quality engineering tasks and ensure manufacturing quality systems are maintained.

Skills

CAPA processes

PFMEA knowledge

Quality data analytics

Non-conformances

Audit support

Education

Bachelor's Degree in Quality/Engineering or similar

Job description

Philips is seeking a Process Quality Engineer to elevate manufacturing quality in Best, NL. You will analyze defects, manage Non-Conformances and Quality Notifications, and drive CAPA actions to prevent recurrence while supporting PFMEA assessments and design transfers.

The role emphasizes data-driven quality improvements, supplier collaboration, and regulatory compliance. Office-based in Best with on-site work required; occasional travel may occur.