On-Site Process Quality Engineer: CAPA & Process Improvement

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

Benefits offered by this job

PTO

401k (match)

HSA

Stock purchase plan

Education reimbursement

Job summary

Philips is hiring a Process Quality Engineer for our Colorado Springs site. The role focuses on high-quality performance, compliance and continuous improvement in a regulated environment, with responsibilities spanning NC/QN analysis, CAPA execution, PFMEA support, and NPI/product transfers.

You will apply advanced statistics to analyze trends, validate processes, and deliver metrics to stakeholders while collaborating with R&D, suppliers, and manufacturing to elevate product quality.

Qualifications

• Minimum 1+ years’ experience in highly regulated product/manufacturing environments (FDA-Medical Device preferred) with focus on Quality/Process Engineering, Continuous Improvement, Design Transfers, CAPA.
• Internship or co-op experience in quality engineering within ISO regulated environments.
• Ability to exercise good judgment within defined procedures/policies to determine appropriate action.

Responsibilities

• Analyzes defects to determine dispositions and manages NCs and QNs; implements effective CAPA actions.
• Supports PFMEA impact assessment and controls related to design changes; assists in Manufacturing Process Development and Design Transfer activities.
• Coordinates quality engineering tasks, ensures manufacturing quality systems are maintained, and assists in NPI and product transfers.
• Applies advanced statistical analysis to interpret data trends and resolve medium to high complexity requests.
• Ensures execution of process validation protocols and supports process improvements.
• Prepares quality metrics and reports for stakeholders, highlighting trends and areas for improvement.
• Participates in investigations and collaborates with suppliers, R&D, and manufacturing to resolve quality issues.

Skills

Quality engineering

CAPA

PFMEA

Root cause analysis

Statistical analysis

Regulated environment

Education

Bachelor's degree in engineering

Job description

Philips is hiring a Process Quality Engineer for our Colorado Springs site. The role focuses on high-quality performance, compliance and continuous improvement in a regulated environment, with responsibilities spanning NC/QN analysis, CAPA execution, PFMEA support, and NPI/product transfers.

You will apply advanced statistics to analyze trends, validate processes, and deliver metrics to stakeholders while collaborating with R&D, suppliers, and manufacturing to elevate product quality.