Process Quality Engineer - Medical Device CAPA & PFMEA

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

Benefits offered by this job

Travel up to 10%

Job summary

Philips Iberica SAU is seeking a Process Quality Engineer to support high-quality performance and compliance across our manufacturing sites, driving continuous quality improvements.

You will analyze defects, manage non-conformances, CAPA actions, and participate in PFMEA assessments, design changes, and NPI transfers, collaborating with suppliers, R&D, and production teams to elevate product quality.

Qualifications

• 2+ years in FDA/ISO 13485 medical device quality environments.
• Experience in CAPA, non-conformances, PFMEA and change control.
• Skilled in quality operations, audit support, process validation and improvement.

Responsibilities

• Analyze defects and manage Non-Conformances (NC) and Quality Notifications (QN).
• Implement corrective and preventive actions (CAPA).
• Support PFMEA assessments and assess impact of design changes.
• Coordinate quality metrics and reports for stakeholders.
• Collaborate with suppliers, R&D and manufacturing to resolve issues.

Skills

Quality operations

CAPA actions

Non-conformances

PFMEA

Data analytics

Statistical analysis

Quality reporting

Education

Bachelor’s degree in Quality/Engineering

Tools

QMS software

Statistical software

CAPA tracking system

Job description

Philips Iberica SAU is seeking a Process Quality Engineer to support high-quality performance and compliance across our manufacturing sites, driving continuous quality improvements.

You will analyze defects, manage non-conformances, CAPA actions, and participate in PFMEA assessments, design changes, and NPI transfers, collaborating with suppliers, R&D, and production teams to elevate product quality.