Process Quality Engineer: CAPA & PFMEA Lead

Philips International; Netherlands; Remote; EUR 49,000 - 81,000; Full time

Job summary

Philips is seeking a Process Quality Engineer to ensure high-quality performance and regulatory compliance in medical device manufacturing. You will analyze defects, drive non-conformances and quality notifications, and implement CAPA actions while supporting PFMEA assessments and design transfers.

The role requires at least 2 years in FDA-regulated ISO 13485 environments, a Bachelor's in Quality or Engineering, and hands-on CAPA and PFMEA experience.

Qualifications

• Minimum 2 years in FDA-regulated (ISO 13485) medical device quality/manufacturing.
• Experience with CAPA, non-conformances, PFMEA, and change management.
• Strong data analytics and quality insights for continuous improvement.
• Bachelor’s degree in Quality, Engineering or related field.

Responsibilities

• Analyze defects to disposition non-conformances and manage QN/CAPA.
• Assess PFMEA impact and support design transfers.
• Coordinate quality systems, NPI and product transfers in factory.
• Collaborate with suppliers, R&D and manufacturing to improve processes.

Skills

Quality engineering

CAPA

PFMEA

Data analytics

Root cause analysis

Education

Bachelor's degree in Quality or Engineering

Tools

Statistical analysis software

Job description

Philips is seeking a Process Quality Engineer to ensure high-quality performance and regulatory compliance in medical device manufacturing. You will analyze defects, drive non-conformances and quality notifications, and implement CAPA actions while supporting PFMEA assessments and design transfers.

The role requires at least 2 years in FDA-regulated ISO 13485 environments, a Bachelor's in Quality or Engineering, and hands-on CAPA and PFMEA experience.