Process Quality Engineer - Medical Devices (On-site)

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

Job summary

Philips seeks a Process Quality Engineer at our Colorado Springs site to support high-quality performance, compliance and continuous improvement across our Image Guided Therapy Devices manufacturing. The role focuses on defect analysis, CAPA, PFMEA, and collaboration with R&D, suppliers and manufacturing to elevate product quality.

This on-site position integrates with operations to sustain regulatory compliance, drive process validation, and contribute to NPI and product transfers within the

Qualifications

• Bachelor's Degree in Engineering is required.
• ASQ certifications are desired.
• Experience in ISO/regulatory environments (FDA-Medical Device preferred) is advantageous.

Responsibilities

• Analyzes defects for disposition and manages Non-Conformances (NC) and Quality Notifications (QN); implements CAPA actions.
• Assists in PFMEA impact assessment and controls related to design changes and manufacturing process development.
• Supports operations performance monitoring, risk assessment, reporting and improvement programs in factory.
• Coordinates quality engineering tasks and facilitates product transfers and New Product Introduction (NPI).
• Applies advanced statistical analysis to interpret data trends and resolve medium to high complexity requests.
• Ensures execution of process validation protocols and coordinates production activities to bolster validation efforts.
• Prepares detailed quality metrics and reports for stakeholders, highlighting trends and improvement opportunities.

Skills

Quality/Process Engineering

Continuous Improvement

CAPA

PFMEA

Root Cause Analysis

Statistical Analysis

Education

Bachelor's Degree in Engineering

Job description

Philips seeks a Process Quality Engineer at our Colorado Springs site to support high-quality performance, compliance and continuous improvement across our Image Guided Therapy Devices manufacturing. The role focuses on defect analysis, CAPA, PFMEA, and collaboration with R&D, suppliers and manufacturing to elevate product quality.

This on-site position integrates with operations to sustain regulatory compliance, drive process validation, and contribute to NPI and product transfers within the