Quality Engineer 1

Overview

Quality Engineer 1 supporting high-quality performance, compliance and continuous/process improvement at Philips' Image Guided Therapy Devices (IGTD) Colorado Springs manufacturing site.

What you'll do

• Analyze defects to determine dispositions and drive management of Non-Conformances (NC) and Quality Notifications (QN), and implement effective Corrective and Preventive Actions (CAPA).
• Assist in assessing impact to Process Failure Mode and Effects Analysis (PFMEA) and controls in relation to design changes.
• Assist in Manufacturing Process Development and Design Transfer activities.
• Support operations performance monitoring, risk assessment, reporting, improvement and development, and aid improvement programs in the factory.
• Support analytical testing and Supplier Quality Engineering (SQE), Supplier Quality Assurance (SQA) and purchasing.
• Coordinate timely quality engineering and quality assurance tasks and help ensure manufacturing quality systems are maintained.
• Help complete New Product Introduction (NPI) and product transfers in the factory.
• Identify process enhancement opportunities and facilitate advanced improvement initiatives to optimize operational performance and elevate product quality.
• Apply advanced statistical analysis techniques to interpret complex data trends and resolve medium to high complexity requests, exercising judgment within defined procedures and practices.
• Ensure the comprehensive execution of process validation protocols and coordinate multifaceted production activities to support process validation and continuous process improvement.
• Prepare and deliver detailed quality metrics and reports to key stakeholders, highlighting achievements, emerging trends, improvement targets and regulatory compliance strategies.
• Participate in investigations and collaborate with suppliers, Research and Development (R&D), and manufacturing teams to resolve quality issues and maintain high standards throughout the supply chain.

What you'll need

• Minimum of 1+ years' experience working in highly regulated product or manufacturing environments with a focus on Quality/Process Engineering, Continuous Improvement, Design Transfers, CAPAs, etc.
• Experience in quality engineering within ISO regulated environments through internship or co-op experience (this is listed as a qualification the candidate has).
• Ability to exercise good judgment working within defined procedures and policies to determine appropriate action, and to work with supervisors and functional peer groups to gain cooperation of others.
• Proven experience participating in investigations and collaborating with suppliers, R&D, and manufacturing teams to resolve quality issues and maintain high standards throughout the supply chain.
• Experience in Risk Assessment (ISO 14971), Process Failure Mode and Effects Analysis (PFMEA) and Root Cause Analysis.
• Experience applying statistical/data analysis techniques to interpret complex data trends, performance monitoring, reporting and resolving medium to high complexity requests.
• Minimum of a Bachelor's Degree in Engineering.
• Ability to perform the minimum physical, cognitive and environmental job requirements, with or without accommodation.

Nice to have

• FDA medical device experience.
• ASQ certifications.

Details

• On-site role at the Colorado Springs, Colorado facility, full-time (5 days per week).
• Must reside in or within commuting distance of Colorado Springs, CO.
• US work authorization is a precondition of employment; no visa sponsorship now or in the future.
• Company relocation benefits will not be provided.
• Pay range $63,000 to $100,000.