What are the responsibilities and job description for the Engineer II, QA position at Oxoid Remel Microbiology (Acquired from Thermo Fisher Scientific)?
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
Minimum Qualifications
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.
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.
- 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.
- 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.
- 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.
- 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.
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.
- 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.
- 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.
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.