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 looking for a Quality Engineer to join the DSP team supporting capital projects in Jaffrey, NH. The world-class Jaffrey Manufacturing Center of Excellence is ISO 9001 and ISO 14001 Certified, practices Six Sigma principles and is an environmentally conscious facility focused on long term sustainability. Duties include:
Provide guidance and support for capital expenditure projects including new equipment and upgrading established processes for both membrane and device manufacturingProviding guidance and support for product and process URS, FAT, qualifications (IQ/OQ/PQ). Work with the cross functional teams to determine the implementation requirements based on applicable industry standards and regulationslead/participate in risk assessment (FMEA)establish acceptance criteriadevelop sampling plansperform data analysisProvide guidance and support in using root cause analysis for the evaluation of deviations / out of specification conditions, and data trending. This includes disposition of non-conforming product and raw materialsLead quality investigations with a cross function team utilizing RCA tools (5-why’s, fishbone) and establishing corrective action plans (CAPA)Perform statistical analysis and trending to assess and monitor product/process performanceCreate / Revise Standard Operating Procedures, Test Methods, and other documents
Who You Are
Minimum Qualifications:
Bachelor of Science degree in Engineering (Chemical, Mechanical, or other Engineering discipline)3+ years Manufacturing or Quality experience in an FDA regulated (pharmaceutical, biotechnology, or medical device) environment
Preferred Qualifications:
Master’s degree in EngineeringKnowledge in ISO & FDA regulations (such as 21 CFR 820, 210 & 211).Ability to conduct quality investigations including root cause analysis and determining corrective / preventative actions, Pragmatic risk-based decision maker with strong problem-solving abilityDemonstrated ability to create and update standard operating proceduresValidation experience in a regulated manufacturing industryStrong communication skills with the ability to collaborate at all levels and functions of the organization and with customers. Operating in a complex, matrixed, fast paced environment and gaining consensus with groupsCollaborative and motivated team playerExperience with relevant data analysis Software / Tools (Minitab) and Methods, working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management)ASQ CQE, Green Belt or Black BeltInfluence/achieve cross functional alignment in a time sensitive manner for critical initiatives, balancing customer/site need
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