Process Quality Engineer - CAPA & Continuous Improvement

Philips International; Colorado Springs (CO); On-site; USD 63,000 - 100,000; Full time

Job summary

Philips Colorado Springs is seeking a Process Quality Engineer to drive high-quality performance and regulatory compliance for our Image Guided Therapy Devices site. You will analyze defects, disposition non-conformances, and lead CAPA actions while supporting PFMEA, design transfers, NPIs and process validation to improve manufacturing quality.

The role requires a Bachelor’s degree in engineering, 1+ year in a regulated environment, and ASQ certifications are preferred.

Qualifications

• Minimum 1+ years in a regulated product/manufacturing environment (FDA‑Medical Device preferred) focusing on Quality/Process Engineering, CI, CAPA, and related activities.
• Experience in ISO‑regulated quality engineering, CAPA, PFMEA, and design transfers.
• BS in Engineering required; ASQ certifications are desirable.

Responsibilities

• Analyze defects to disposition non-conformances (NC) and manage quality notifications (QN).
• Lead CAPA actions and support PFMEA assessments and design changes.
• Assist in manufacturing process development and design transfer activities.
• Support operations performance monitoring, risk assessment, reporting and improvement programs.
• Coordinate quality engineering tasks to maintain manufacturing quality systems.
• Participate in New Product Introduction (NPI) and product transfers.
• Collaborate with suppliers, R&D, and manufacturing to resolve quality issues.

Skills

Quality engineering

CAPA management

PFMEA

Root cause analysis

Statistical analysis

Risk assessment

Design transfer

Regulated environment

Education

Bachelor’s Degree in Engineering

Job description

Philips Colorado Springs is seeking a Process Quality Engineer to drive high-quality performance and regulatory compliance for our Image Guided Therapy Devices site. You will analyze defects, disposition non-conformances, and lead CAPA actions while supporting PFMEA, design transfers, NPIs and process validation to improve manufacturing quality.

The role requires a Bachelor’s degree in engineering, 1+ year in a regulated environment, and ASQ certifications are preferred.