Senior Quality Engineer - NPD, Validation & Risk Lead

Katalyst CRO; Austin (TX); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO in Austin, TX seeks a Quality Engineer to lead QA activities for new product development, tech transfer, and acquisitions. The role focuses on process and equipment validations, risk analysis, and ongoing quality improvements across cross-functional teams.

You will review validation protocols, manage RMFs, and drive CAPA investigations while maintaining compliance with GMPs, QSR, and ISO standards. This is a full-time onsite position in Austin with growth during the expansion period.

Qualifications

• Bachelor's degree in Engineering or a science-related field (or equivalent work experience)
• Strong understanding of statistical methods and acceptance sampling in regulated environments
• Proficient with PC tools (Word, Excel, data analysis software)
• Review and analyze validations for equipment, processes, and software
• Communicate effectively with all levels of the organization
• Manage and prioritize multiple projects in a fast-paced environment
• Maintain RMFs and evaluate post-production data for impact

Responsibilities

• Provide Quality Engineering leadership for NPD, tech transfer, and acquisitions
• Lead resolution of quality issues across cross-functional teams
• Review and approve validations for equipment, processes, and software
• Collect, analyze, and present statistical data to support validations and engineering studies
• Assist in developing, implementing, and documenting qualifications/validations
• Perform calibration activities as required
• Partner with Facilities to ensure proper preventive maintenance
• Collaborate with manufacturing facilities as needed
• Maintain Risk Management Program policies and documentation
• Identify hazards, risk probabilities, severities, and mitigations for Risk Analyses
• Ensure periodic Risk Management File reviews occur on schedule
• Evaluate labeling, process, and product changes for RMF impact
• Monitor post-market data (complaints, CAPAs, NCRs, customer feedback)
• Provide investigation reports, evaluations, and risk assessments to other departments
• Support translation of design input requirements into design outputs
• Own sampling plan strategy across defect types, severity, patient risk, process capability, and classification
• Establish and/or maintain Risk Management Files for product lines and corporate projects
• Review and approve verification/validation protocols and reports
• Conduct investigation, documentation, and approval of non-conformances, CAPAs, and complaints

Job description

Katalyst CRO in Austin, TX seeks a Quality Engineer to lead QA activities for new product development, tech transfer, and acquisitions. The role focuses on process and equipment validations, risk analysis, and ongoing quality improvements across cross-functional teams.

You will review validation protocols, manage RMFs, and drive CAPA investigations while maintaining compliance with GMPs, QSR, and ISO standards. This is a full-time onsite position in Austin with growth during the expansion period.