Quality Engineer III

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

We are seeking a talented Quality Engineer to join our team, supporting New Product Introduction at our Jaffrey, NH location. The Jaffrey Manufacturing Center of Excellence is a world-class facility, ISO 9001 and ISO 14001 certified, and committed to Six Sigma principles. With a strong focus on environmental responsibility and long-term sustainability, it is a leading example of operational excellence.

• Collaborate with Product Development and Product Management teams to introduce new products and/or line extensions into the Jaffrey facility.
• Act as a liaison between product development and the plant, providing guidance and support for device manufacturing.
• Lead and participate in the creation of risk assessments, including product and process FMEAs (Failure Modes and Effects Analysis).
• Provide guidance and support for product validation and equipment qualifications, including establishing acceptance criteria, sampling plans, and performing data analysis.
• Write validation protocols and reports, ensuring compliance with regulatory standards.
• Create and revise Standard Operating Procedures (SOPs), test methods, and other related documents.
• Perform statistical analysis and trending to assess and monitor product and process performance.
• Offer guidance for the disposition of non-conforming products and raw materials, including evaluating deviations/out-of-specification conditions, trending data, and leading quality investigations (root cause analysis and corrective action plans).
• Support shelf-life studies (both accelerated and real-time aging), including protocol creation, sample submission, data analysis, out-of-specification investigation, and report creation.

Who You Are

Minimum Qualifications:

• Bachelor of Science degree in Engineering (Chemical, Mechanical, or other Engineering discipline).
• 3+ years Quality Engineering experience in a manufacturing environment.

Preferred Qualifications:

• Master’s degree in Engineering (Chemical, Mechanical, or other Engineering discipline).
• Knowledge in ISO 9001:2015.
• 5+ years Quality Engineering experience in manufacturing; experience in an FDA regulated  (pharmaceutical, biotechnology, or medical device) environment.
• Strong communication skills with the ability to collaborate at all levels and functions of the organization and with customers, operate in a complex, matrixed, and fast paced environment and gain consensus with groups.
• Validation experience in a regulated manufacturing industry.
• Conduct quality investigations including root cause analysis and determining corrective / preventative actions, pragmatic risk-based decision maker with strong problem-solving skills.
• Demonstrated ability to create and update standard operating procedures.
• Collaborative and motivated team player.
• Experience with relevant data analysis Software / Tools (Minitab) and Methods, working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management).
• ASQ CQE, Six Sigma Green Belt or Black Belt.

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