Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
At MilliporeSigma, as the Quality Assurance Specialist you have responsibility for the Post Market Surveillance activities with our Cell Marque IVD products. This role is key in monitoring the safety and effectiveness of IVD products after they have been marketed. The Post Market Surveillance Quality Assurance Specialist will be responsible for collecting and analyzing post market data, investigating field corrective actions, ensuring regulatory compliance and providing insight for continuous improvement of our products.
Key Responsibilities:
- Monitor and analyze post market data from various sources, including customer feedback, complaints, field corrective actions and literature reviews.
- Ensure compliance with post market surveillance regulations and contribute to the development and maintenance of post market surveillance plans, procedures and reports.
- Collaborate with cross functional teams to assess the impact of field corrective actions, and support risk management activities, including root cause analysis and risk mitigation strategies.
- Perform statistical analysis and trend analysis on post market data to identify potential improvements, safety concerns and market performance.
- Support the development, implementation, and monitoring of Corrective and Preventive Action (CAPA) plans resulting from post market surveillance findings.
- Prepare post market surveillance reports.
- Collaborate with R&D, Medical Office and Quality on customer complaint analysis
Who You Are:
Minimum Qualifications:
- Bachelor’s Degree in a scientific discipline (e.g., Biology, Chemistry, Microbiology, etc.)
Preferred Qualifications:
- 1+ years of experience in a quality role
- Strong analytical, problem-solving and communication skills.
- Proficiency in data analysis and trending techniques.
- Strong understanding of risk management and CAPA processes.
- Ability to work autonomously, effectively manage time and deliver results on time.
- Strong attention to detail and a commitment to quality and regulatory compliance.
- Understanding or experience with ISO & FDA regulations.
Cell Marque STL
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
