Quality Engineer 2

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

• Provide guidance and support for device manufacturing. This includes the evaluation of deviations / out of specification conditions, data trending, and leading quality investigations: root cause analysis, corrective action plans and customer complaints.
• Provide guidance and support for product and process changes by working with the cross-functional team to determine the implementation requirements based on applicable industry standards and regulations.
• Provide guidance and support for product validation and equipment qualifications including establishing acceptance criteria, sampling plans and performing data analysis.
• Write or approve validation protocols and reports.
• Create or revise Standard Operating Procedures, Test Methods and other documents.
• Maintains compliance to ISO 9001 and QSR (cGMP) for medical devices in the department functions and responsibilities.
• Perform statistical analysis and trending to assess and monitor product or process performance.
• Provide guidance and approve the disposition of non-conforming product and raw materials. Lead daily quality review board meetings of assigned area.
• Lead and participate in the creation of risk assessments (e.g. design and process FMEA).
• Lead projects with cross functional teams to improve in-process quality, reduce customer complaints, and increase production efficiency
• Provide guidance and support for shelf-life studies both accelerated and real-time aging. Including protocol creation, sample submission, data analysis, out of specification investigation, and report creation
  
  

A Shift: Monday - Friday 8AM - 5PM

Who You Are

Minimum Qualifications:

• Bachelor’s of Science degree in Engineering, Biology, or Chemistry.
• 2 years manufacturing or Quality experience in an FDA regulated (pharmaceutical, biotechnology, or medical device) environment
  
  

Preferred Qualifications

• 5 years of Quality Engineering experience in a FDA regulated (pharmaceutical, biotechnology, or medical device) manufacturing setting with proven track record of successful performance.
• Experience with ISO & FDA regulations (such as ISO 9001, ISO 13485 or 21 CFR 820, 210 & 211).
• Create and update standard operating procedures ("SOP").
• Validation experience in a regulated manufacturing industry.
• 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.
• Conduct quality investigations including root cause analysis and determining corrective / preventative actions.
• Collaborative and motivated team player.
• Perform job duties with minimal oversight and guidance
• Pragmatic risk-based decision maker with strong problem-solving ability.
• Experience with relevant data analysis software tools (Minitab) and methods
• Working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management).
• MS in Engineering, Biology, or Chemistry.
• ASQ CQE.
• 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