Engineer II, QA

Oxoid Remel Microbiology (Acquired from Thermo Fisher Scientific); Lenexa (KS); On-site; USD 60,000 - 90,000; Full time

Job summary

Oxoid Remel Microbiology seeks a QA Specialist, Quality Notifications to support customer complaints, product investigations, and regulatory compliance. The role emphasizes scientific investigations, documentation review, and timely communication of findings.

You will work with Quality, Manufacturing, Technical Services, and other teams to drive corrective actions, continual improvement, and strong product quality in a regulated setting.

Qualifications

• Bachelor's degree in a scientific or related discipline.
• At least 1 year of experience in a regulated environment (medical device, pharmaceutical, biotechnology, or clinical lab).
• Laboratory experience and familiarity with laboratory documentation.
• Proficiency with Excel and PowerPoint for data and reporting.

Responsibilities

• Lead internal quality investigations and root-cause analysis.
• Investigate customer complaints and product performance issues.
• Collaborate with cross-functional teams to implement corrective actions.
• Review Device History Records and quality documentation for accuracy.
• Communicate investigation findings to stakeholders and customers.
• Monitor quality metrics and report to the Quality Review Board.

Skills

Analytical skills

Problem solving

Communication skills

Organizational skills

Attention to detail

Cross-functional collaboration

Education

Bachelor's degree in a scientific field

Tools

Microsoft Excel

Microsoft PowerPoint

Job description

Make an Impact

Joining Oxoid Remel Microbiology means becoming part of a team dedicated to making a meaningful difference in healthcare, food safety, and pharmaceutical manufacturing. Our products and solutions support accurate disease identification, targeted treatment, and the quality and reliability of microbiology testing around the world.

With a long-standing reputation for scientific excellence, quality, and innovation, we are committed to delivering products that meet the highest standards of performance and regulatory compliance.

As a QA Specialist, Quality Notifications, you'll play an important role in maintaining product quality, investigating customer concerns, and ensuring compliance with established quality systems and regulatory requirements.

You’ll work closely with Quality, Manufacturing, Technical Services, and cross-functional teams to investigate product issues, identify root causes, implement corrective actions, and support continuous improvement initiatives.

About the Role

The QA Specialist, Quality Notifications is responsible for supporting quality assurance activities related to customer complaints, product investigations, quality notifications, and regulatory compliance.

This role involves conducting scientific and technical investigations, reviewing quality documentation, evaluating product performance, and communicating investigation findings to internal stakeholders and customers.

The ideal candidate brings a strong scientific foundation, excellent analytical and problem‑solving skills, attention to detail, and the ability to work collaboratively in a regulated environment.

What You Will Do

Quality Investigations & Problem-Solving

• Lead internal quality investigations, including product evaluations and process reviews, to identify root causes of quality concerns.
• Investigate customer complaints and product performance issues, ensuring timely and thorough resolution.
• Partner with cross-functional teams to identify, implement, and monitor appropriate corrective actions.
• Apply structured problem‑solving techniques to investigate deviations, product failures, and quality‑related concerns.
• Support continuous improvement initiatives designed to strengthen product quality and operational effectiveness.

Quality Systems & Regulatory Compliance

• Ensure quality activities comply with applicable regulatory requirements, including 21 CFR Part 820, ISO 13485, and other relevant international standards.
• Support the development, implementation, maintenance, and monitoring of Quality Management System procedures.
• Review Device History Records (DHRs), processing records, and other quality documentation to ensure accuracy, completeness, and compliance.
• Maintain accurate investigation records, quality documentation, and supporting data in accordance with established procedures.
• Identify potential compliance risks and collaborate with appropriate stakeholders to address concerns.

Microbiology Testing & Product Evaluation

• Conduct microbiological product performance testing using ATCC reference organisms and established laboratory procedures.
• Evaluate microbiological testing results to support product investigations and customer complaint resolution.
• Collaborate with laboratory and technical teams to assess product performance and identify potential quality concerns.
• Maintain accurate testing documentation and communicate findings to relevant stakeholders.

Customer Communication & Quality Notifications

• Prepare clear, accurate, and professional written responses to customer quality notifications, complaints, and product inquiries.
• Collaborate with customers, Technical Services, and internal teams to investigate and resolve product-related concerns.
• Provide technical guidance and support regarding product quality and complaint investigations.
• Ensure timely communication of investigation findings, corrective actions, and resolution status.

Reporting, Metrics & Continuous Improvement

• Monitor, analyze, and report quality metrics related to customer complaints, product handling, stability testing, and product performance.
• Prepare and present quality information to the Quality Review Board and other stakeholders.
• Identify trends, recurring issues, and opportunities for process improvement through data analysis.
• Support initiatives to improve investigation efficiency, documentation accuracy, and overall quality performance.
• Collaborate across departments to strengthen quality processes and customer satisfaction.

What You Will Bring

Minimum Qualifications

• Bachelor's degree in a scientific or related discipline.
• Minimum of 1 year of experience in a regulated environment, such as medical device, pharmaceutical, biotechnology, or clinical laboratory operations.
• At least 2 semesters or 1 year of laboratory experience.
• Experience working with laboratory procedures, testing practices, and scientific documentation.
• Proficiency in Microsoft Office applications, particularly Excel and PowerPoint.
• Strong analytical, organizational, and problem‑solving skills.
• Excellent written and verbal communication abilities.
• Strong attention to detail and the ability to manage multiple priorities.
• Ability to collaborate effectively with cross‑functional teams.

Preferred Qualifications

• 2+ years of experience in a regulated medical device, pharmaceutical, biotechnology, or clinical environment.
• Experience working in a Quality Control Microbiology Laboratory.
• Familiarity with FDA Quality System requirements, ISO 13485, and regulated quality processes.
• Experience supporting customer complaint investigations, root cause analysis, and corrective actions.

Knowledge of quality tools and methodologies, including:

• Structured problem-solving
• Root cause analysis
• Data trending and analysis
• Failure Mode and Effects Analysis (FMEA)
• Experience reviewing quality documentation, laboratory records, and product testing results.
• Experience with microbiological testing and product performance evaluations.

Join Us

This is an exciting opportunity to join Oxoid Remel Microbiology and contribute to a team focused on delivering high-quality products that support critical microbiology and diagnostic testing worldwide.

With more than 100 years of microbiology expertise, we are proud of our trusted brands, scientific innovation, and commitment to helping customers solve important challenges across healthcare, food safety, and pharmaceutical manufacturing.

As a QA Specialist, Quality Notifications, you'll have the opportunity to apply your scientific knowledge, strengthen quality processes, collaborate with experienced professionals, and contribute directly to product reliability and customer satisfaction.

If you're a detail-oriented, analytical professional who enjoys investigating complex problems, collaborating across teams, and making a meaningful impact on product quality, we’d love to hear from you.

Come be part of what's next at Oxoid Remel Microbiology.