St. Louis, Missouri, USA
21 days ago
Senior Quality Assurance Supervisor

 

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:

This position is located at the Ewing location. The Quality Assurance Supervisor will have responsibility for quality assurance aspects of the Quality Management System (QMS) to ensure that process and procedures are following ISO 9001, ISO 13485, and current Good Manufacturing Practices (cGMP). The Quality Assurance Senior Supervisor provides leadership and expertise on quality assurance processes and tools. They will lead a team that manages processes such as Deviation, CAPA, Change Control, Training, Complaint Management, and Document Control. In addition, they will have responsibility to ensure that the site is in a state of continuous inspection readiness. The Quality Assurance Senior Supervisor will report directly to the Head of Quality.

 

Responsibilities include but are not limited to:

Manage Quality Management System (QMS) to ensure alignment with corporate and regulatory standards such as ISO 9001, ISO 13485, and cGMP. Hire, train and develop qualified staff to ensure effective execution of quality assurance tasks and attain operational and development goals. Drive achievement of site vision and goals / objectives. · Ensure application of risk management and sound root cause analysis. Analyze and report quality measures, performance trends and improvements. Support the initiation and management of quality improvement plans. Provide Quality Management Systems training to site employees as part of the Learning management system. Review and approve quality documentation such as procedures, deviation/CAPA plans, risk assessments and change controls to ensure compliance. Provide quality assurance support to new product introduction and contract manufacturing activities.

 

Who You Are:

Minimum Qualifications:

Bachelors Degree in Biology, Chemistry, or other Life Science discipline. 3+ years of work experience in a quality leadership role.

 

Preferred Qualifications:

Experience with ISO 9001, ISO 13485 and 21CFR GMP requirements and guidelines. Experience with Microsoft Office and Quality systems (Trackwise) software.


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

 

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