Merck KGaA

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 motivated Quality Engineering Supervisor to support device manufacturing at the Jaffrey Manufacturing site. This position will manage a small team of Quality Engineers and Quality Technicians and oversee three rapidly growing manufacturing work centers, partnering with Operations, Engineering, Product Management (Marketing) and EHS. The candidate’s ability to apply fundamental engineering techniques and lean/six sigma principles to enhance product performance is crucial to this role. The Supervisor will provide guidance and mentorship to his/her expanding team of quality engineers and quality technicians. In addition to the supervisory requirements, the candidate will also be responsible for providing day-to-day Quality Engineering support for a fast-paced device manufacturing operation, including:

• Evaluation of out-of-specification conditions and providing guidance for the disposition of non-conforming product and raw materials,
• Leading quality investigations (RCA and CAPA management)
• Perform statistical analysis and trending to assess and monitor product/process performance,
• Working with cross functional teams to set the requirements to support product and process modifications; ensuring that Change Control requirements are met based on internal company procedures and applicable industry standards and regulations
• Lead and participate in the creation of risk assessments (product and process- FMEA)
• Participate in product validation and equipment qualifications by establishing acceptance criteria, statistical sampling plans, data analysis, and write validation protocols and reports
• Create / revise Standard Operating Procedures, Test Methods, and other documents

Who You Are

Minimum Qualifications:

• Bachelors Degree in Biology, Mechanical Engineering, or other Life Science or Engineering discipline
• 2+ years of Quality Engineering experience

Preferred Qualifications:

• Master’s degree in Biology, Mechanical Engineering, or other Life Science or Engineering discipline
• Leadership experience in an FDA regulated environment (pharmaceutical, biotechnology, or medical device)
• Understanding or experience with ISO & FDA regulations (such as 21 CFR 820, 210 & 211)
• Demonstrated ability to conduct quality investigations including root cause analysis and determining corrective / preventative action
• Strong communication skills with the ability to collaborate with Customers and at all levels and functions of the organization.
• Pragmatic risk-based decision maker with strong problem-solving
• Collaborative and motivated team player
• Experience with relevant data analysis software (i.e., Minitab)
• Working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management)
• Black Belt or Green Belt

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!