Job Title:
Senior Quality Engineer
Job Description:
The Role
Our site in Colorado Springs, CO is seeking an ONSITE Senior Quality Engineer to join our UPE Membrane team. This role will be a critical member of the team bringing a new membrane manufacturing operation through startup, qualification, customer approval, and production ramp.
You will work hands-on with Operations, Process Engineering, Equipment Engineering, Metrology, R&D, and Quality to define and implement the controls needed for a capable and customer-ready manufacturing process. Key responsibilities include developing PFMEAs and control plans, establishing inspection and reaction strategies, implementing statistical process controls, and helping assemble validation and qualification evidence for customer data packages.
This role complements the Lead Process & Quality Engineer. The Lead role spans overall process startup, technology transfer, validation strategy, and manufacturing readiness; the Senior Quality Engineer drives detailed quality execution, control implementation, documentation, and validation-package support. The ideal candidate enjoys working directly on the manufacturing floor and can turn process and product risk into practical, controlled, and documented quality systems.
What You'll Do
Provide hands-on startup quality engineering support as the Rockrimmon UPE membrane operation moves through equipment qualification, process validation, customer qualification, and production ramp.
Lead development and implementation of PFMEAs, control plans, process flows, inspection plans, sampling strategies, specifications, acceptance criteria, out-of-control action plans, and reaction plans for new membrane manufacturing processes.
Partner with Process Engineering, Operations, R&D, and Metrology to identify critical-to-quality characteristics, define measurement strategies, establish process windows, and translate validation learning into effective manufacturing controls.
Work directly on the manufacturing floor during startup and qualification activities to verify that controls are practical, operating as intended, and accurately reflected in procedures and records.
Implement SPC and process-monitoring strategies for critical product and process characteristics; analyze capability, variation, yield, defect, and metrology data to identify risk and drive action.
Assist with preparation, review, and compilation of customer validation and qualification packages, including protocols, test results, capability data, measurement-system evidence, deviations, conclusions, and traceable supporting records.
Support execution and documentation of process characterization, validation, and qualification activities, including MSA, GR&R, bias, correlation, capability, and method-validation studies.
Partner with the Lead Process & Quality Engineer and technical subject matter experts at i2M and other Entegris locations to align critical controls, test methods, acceptance criteria, and qualification evidence.
Author, revise, and implement quality procedures, inspection methods, work instructions, forms, records, training requirements, and other QMS documentation needed for startup and operational readiness.
Lead investigations involving nonconforming material, process deviations, startup issues, internal defects, customer concerns, and quality escapes using structured root cause and corrective-action methods.
Drive containment, corrective action, effectiveness verification, and recurrence prevention through 8D, 5-Why, fishbone, fault-tree, or equivalent methodologies.
Review product and process data to support deviation assessment, lot disposition, release decisions, escalation, and risk-based decision making during qualification and ramp.
Conduct readiness reviews, process audits, and quality-system audits to confirm procedures, controls, training, metrology, records, and reaction systems are implemented and effective.
Develop and monitor startup quality metrics and lead…