Quality Engineer II: QMS & CAPA Champion

Oxoid Remel Microbiology (Acquired from Thermo Fisher Scientific); Lenexa (KS); On-site; USD 75,000 - 110,000; Full time

Job summary

Oxoid Remel Microbiology seeks a Quality Engineer II – QMS Compliance to strengthen the Quality Management System and drive continuous improvement. You will partner across Operations, Quality Control, Engineering and Manufacturing Sciences to investigate quality events, perform RCA, and implement CAPA and MOC actions in a controlled, compliant manner.

The role emphasizes QMS metrics, audit readiness, and ongoing process improvements to uphold GMP/ISO standards in a highly regulated environment.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, or a related technical discipline.
• Experience with quality systems in regulated environments.
• Strong root cause analysis and problem-solving capabilities.

Responsibilities

• Lead investigations and root cause analyses for quality events.
• Support CAPA, MOC, and change-control activities.
• Ensure risk assessments and timely actions are completed.
• Monitor QMS records for aging, overdue actions, and compliance risks.
• Collaborate across Operations, Quality, and Engineering to drive improvements.
• Assist with audit readiness and responses to observations.

Skills

Quality management

Investigation & RCA

Problem solving

Cross-functional collaboration

Documentation skills

Education

Bachelor's degree in Engineering or Science

Tools

eQMS

Job description

Oxoid Remel Microbiology seeks a Quality Engineer II – QMS Compliance to strengthen the Quality Management System and drive continuous improvement. You will partner across Operations, Quality Control, Engineering and Manufacturing Sciences to investigate quality events, perform RCA, and implement CAPA and MOC actions in a controlled, compliant manner.

The role emphasizes QMS metrics, audit readiness, and ongoing process improvements to uphold GMP/ISO standards in a highly regulated environment.