Quality Engineer – Process Focus

About the role

The Process Quality Engineer supports high‑quality performance, compliance and continuous improvement at Philips' Image Guided Therapy Devices manufacturing site in Colorado Springs. You will analyze defects, drive corrective actions and ensure robust process validation.

Key responsibilities

• Analyze defects, manage Non‑Conformances (NC) and Quality Notifications (QN), and implement CAPA actions.
• Support PFMEA updates, risk assessments (ISO 14971) and design change controls.
• Coordinate manufacturing process development, design transfer and new product introduction activities.
• Perform advanced statistical analysis to interpret data trends and resolve medium to high‑complexity requests.
• Prepare and deliver quality metrics and reports to stakeholders.

Required profile

• Minimum 1 + year experience in regulated product/manufacturing environments (FDA‑Medical Device preferred).
• Bachelor’s degree in Engineering; ASQ certification desired.
• Experience participating in investigations with suppliers, R&D and manufacturing teams.
• Ability to work onsite full‑time in Colorado Springs.

Required skills

• PFMEA and risk assessment (ISO 14971) methodology.
• Root cause analysis and CAPA implementation.
• Statistical and data analysis techniques for process improvement.
• Process validation and continuous improvement practices.

What we offer

• Competitive salary range $63,000‑$100,000 per year.
• Comprehensive benefits including generous PTO, 401(k) with up to 7% match, HSA contributions, stock purchase plan and education reimbursement.
• Opportunity to work on cutting‑edge medical device manufacturing in a collaborative environment.