Senior Quality Engineer - NPD, Risk & Compliance

Katalyst CRO; Little Rock (AR); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO in Little Rock, AR is seeking a Quality Engineer to lead QA efforts across new product development, tech transfer, and acquisitions, ensuring compliance with GMPs, QSR, and ISO standards. You will review validations, analyze data, and drive CAPAs while collaborating with cross-functional teams to support product launches.

In this role you will maintain RMF documentation, perform risk assessments, and ensure design controls are applied.

Qualifications

• Bachelor's degree in Engineering or science-related field.
• 5-10 years of hands-on experience in FDA-regulated industries.
• Strong IQ/OQ protocol writing and validation experience.
• Solid knowledge of GMPs, QSR, and ISO standards.
• Proficiency with data analysis and statistics.
• ASQ CQE/CQA certifications 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 studies.
• Assist in developing, implementing, and documenting qualifications/validations.
• Perform calibration activities as required.
• Maintain Risk Management Program policies and documentation.
• Identify hazards, risk probabilities, severities, and mitigations for RMF analyses.
• Ensure periodic RMF reviews occur on schedule.
• Review and approve verification/validation protocols and reports.
• Conduct investigations of non-conformances, CAPAs, and complaints.

Skills

Quality Engineering leadership

Risk management

FDA-regulated industry experience

Statistical methods

Validation/verification

Education

Bachelor's degree in Engineering or science

Job description

Katalyst CRO in Little Rock, AR is seeking a Quality Engineer to lead QA efforts across new product development, tech transfer, and acquisitions, ensuring compliance with GMPs, QSR, and ISO standards. You will review validations, analyze data, and drive CAPAs while collaborating with cross-functional teams to support product launches.

In this role you will maintain RMF documentation, perform risk assessments, and ensure design controls are applied.