Senior Quality Engineer: NPD & Risk Leader

Katalyst CRO; Little Rock (AR); On-site; USD 65,000 - 95,000; Full time

Job summary

Katalyst CRO seeks an experienced Quality Engineer to drive QA/QA for NPD, tech transfer, and acquisitions. You will lead risk analyses, support design controls, and ensure GMP/QSR/ISO compliance across the product lifecycle.

The role requires strong statistical methods, IQ/OQ protocol writing, and collaboration with cross-functional teams to maintain RMFs and support continuous improvement.

Qualifications

• Bachelor's degree in Engineering or a science-related field (or equivalent work experience).
• 5-10 years of hands-on experience in an FDA-regulated industry (pharmaceutical, biomedical, or medical device) with strong knowledge of GMPs, QSR, and ISO standards main focus will be to perform validations during this growth period over the next year.
• Specialized in equipment/process; strong IQ/OQ and protocol/report writing.
• Strong understanding of statistical methods and acceptance sampling in regulated environments.
• Proficient with PC tools (Word, Excel, data analysis software).
• ASQ, CQE, or CQA certifications preferred but not required.
• Risk Management experience preferred but not required.

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
• Maintain knowledge of applicable standards, regulations, and procedures
• Support creation and review of Design History File documents
• Perform internal and supplier audits as assigned
• Analyze non-conformances and implement corrective and preventive actions
• Execute high-visibility Risk Management projects as needed
• Partner with Sustaining Engineering to support new product development and commercial launch
• Ensure proper application of design controls, risk management, and investigation/correction of design issues
• 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 RMFs 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

Skills

Quality Engineering

Risk Management

Statistical Methods

Data Analysis

Cross-Functional Leadership

Education

Bachelor's degree in Engineering or a science-related field

Job description

Katalyst CRO seeks an experienced Quality Engineer to drive QA/QA for NPD, tech transfer, and acquisitions. You will lead risk analyses, support design controls, and ensure GMP/QSR/ISO compliance across the product lifecycle.

The role requires strong statistical methods, IQ/OQ protocol writing, and collaboration with cross-functional teams to maintain RMFs and support continuous improvement.