QE Engineer II - QMS Compliance

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

Joining Oxoid Remel Microbiology, you’ll play an active part in helping deliver meaningful impact. We play a crucial role in supporting accurate disease identification and targeted treatment, food and beverage safety, and pharmaceutical manufacturing integrity. Our products and services are designed to meet high standards of quality and performance, helping our customers achieve their objectives efficiently and effectively.

As a Quality Engineer II – QMS Compliance, you’ll help strengthen our Quality Management System and support a culture of quality, compliance, accountability, and continuous improvement. You’ll partner across the organization to investigate quality events, identify true root causes, develop effective corrective actions, assess risk, and ensure changes are implemented in a controlled and compliant manner.

About the Role

The Quality Engineer II – QMS Compliance provides quality systems and compliance support to ensure the effective execution and continuous improvement of the site Quality Management System (QMS).

This role partners cross-functionally with Operations, Quality Control, Engineering, Manufacturing Sciences, and other functional teams to support the timely and compliant execution of investigations, Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and Management of Change (MOC).

The Quality Engineer II will serve as a subject matter resource for investigation and quality system processes, helping teams identify true root causes, develop effective corrective and preventive actions, assess risk, and ensure changes are appropriately evaluated and implemented.

The position will also support QMS metrics, compliance monitoring, audit readiness, and continuous improvement initiatives.

What You Will Do

• Investigations & Root Cause Analysis
• Provide Quality oversight and technical support for deviations, nonconformances, investigations, and other quality events.
• Facilitate and/or support structured Root Cause Analysis using appropriate problem-solving tools and methodologies.
• Partner with investigation owners and cross-functional teams to ensure investigations are thorough, scientifically sound, risk-based, and completed within established timelines.
• Help teams distinguish symptoms from true root causes and appropriately challenge conclusions when supporting evidence is insufficient.
• Provide coaching and guidance to cross-functional personnel on investigation practices and root cause analysis methodologies.
• CAPA Management
• Support the development, implementation, and closure of effective Corrective and Preventive Actions (CAPAs).
• Evaluate CAPA plans to ensure actions appropriately address identified root causes and reduce the likelihood of recurrence.
• Support CAPA effectiveness verification activities, including establishing meaningful effectiveness criteria and reviewing supporting data.
• Monitor CAPA records for aging, overdue actions, recurring issues, and potential compliance risks.

Management of Change & Change Control

• Provide Quality support for Management of Change (MOC) and change-control activities.
• Assess proposed changes for potential impact to product quality, validated processes, procedures, equipment, facilities, materials, training, and regulatory requirements.
• Ensure appropriate risk assessments, implementation activities, approvals, documentation, and post-implementation requirements are completed.
• Partner cross-functionally to ensure changes are appropriately evaluated and implemented without compromising product quality or compliance.

QMS Compliance & Continuous Improvement

• Monitor QMS records for aging, overdue actions, recurring issues, and compliance risks.
• Support trending and analysis of investigation, CAPA, MOC, and other QMS performance metrics to identify systemic issues and improvement opportunities.
• Review and approve Quality System records in accordance with established procedures and applicable requirements.
• Identify opportunities to improve QMS processes, reduce record cycle time, improve right-first-time documentation, and strengthen overall compliance.
• Participate in cross-functional quality improvement projects and site quality initiatives.
• Support the development and revision of procedures, work instructions, forms, and other controlled Quality System documentation.
• Promote a culture of quality, accountability, compliance, and continuous improvement.
• Perform additional Quality System responsibilities as assigned.
• Audit & Inspection Readiness
• Support internal, customer, corporate, and regulatory audit-readiness activities.
• Assist with responses and remediation activities associated with audit observations and Quality System findings.
• Help ensure Quality System records and supporting documentation remain accurate, complete, timely, and inspection-ready.

Minimum Qualifications

• Bachelor’s degree in Engineering, Science, Quality, or a related technical discipline.
• Typically 3+ years of experience in Quality Assurance, Quality Engineering, manufacturing quality, or Quality Systems within a regulated environment.
• Experience supporting or managing investigations, deviations, nonconformances, CAPAs, change controls, or other QMS processes.
• Working knowledge of Root Cause Analysis and structured problem-solving methodologies.
• Strong technical writing and documentation skills.
• Demonstrated ability to evaluate data, identify trends, assess risk, and develop practical solutions.
• Ability to work effectively with cross-functional teams and influence without direct authority.
• Strong organizational skills with the ability to manage multiple priorities and timelines.

Preferred Qualifications

• Experience within pharmaceutical, biotechnology, medical device, diagnostics, life sciences, or another highly regulated manufacturing environment.
• Experience working within an electronic Quality Management System (eQMS).
• Experience with investigation and Root Cause Analysis tools such as 5 Why, Fishbone/Ishikawa, Fault Tree Analysis, Kepner-Tregoe, or similar methodologies.
• Experience with CAPA effectiveness verification and Quality System trending.
• Familiarity with risk-management tools such as FMEA.
• Experience supporting internal or external audits.
• Working knowledge of applicable GMP, FDA, ISO, and other regulatory or Quality System requirements.
• Lean, Six Sigma, Practical Process Improvement (PPI), or other continuous improvement experience is beneficial.

Knowledge, Skills & Abilities

• Strong understanding of Quality Management System principles.
• Strong investigation, analytical, and critical-thinking skills.
• Ability to distinguish symptoms from true root causes and challenge conclusions when supporting evidence is insufficient.
• Ability to translate complex quality issues into clear actions and expectations.
• Strong attention to detail while maintaining focus on overall compliance and business risk.
• Ability to appropriately prioritize quality events based on product, process, compliance, and patient/customer risk.
• Effective verbal and written communication skills.
• Strong interpersonal skills with the ability to collaborate across multiple functions and organizational levels.
• Comfortable coaching others and providing constructive Quality guidance.
• Demonstrated ownership, accountability, and follow-through.

Join Us

This is an exciting time to join Oxoid Remel Microbiology as we continue building on our established expertise and long-standing reputation in microbiology. Quality is fundamental to the products we manufacture and the customers we serve, and our Quality teams play an important role in ensuring our systems, processes, and products consistently meet established requirements.

We’re looking for someone who enjoys solving complex problems, digging beyond symptoms to identify true root causes, collaborating across functions, and turning Quality System requirements into practical and sustainable improvements. If you’re ready to bring your Quality expertise to an organization where your work can have a meaningful impact, we’d love to hear from you.