Quality Engineer I

Posted 15 Dec 2022

Sheboygan Falls, Wisconsin - United States

Req Id 259284


Work Your Magic with us!

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 Quality Engineer position will support the development, maintenance, and improvement of quality systems, and ensure their alignment with business goals, premier customer expectations and global business unit best practices. Duties within the scope of this description are focused on quality system development and maintenance, attention to detail, quality deployment activities including process and statistical control, reporting for internal and external customers, employee training, change management, non-conforming product management, and management of the Business Continuity Program.   


  • Provide guidance and support for product and process changes by working with the multi-functional team to determine the implantation requirements based on applicable industry standards and regulations
  • Support product validation and equipment qualifications including establishing acceptance criteria, sampling plans, and performing data analysis
  • Write or approve validation protocols and reports
  • Write or revise Standard Operating Procedures and other documents
  • Maintain compliance to ISO 9001 in the department functions and responsibilities
  • Perform statistical analysis and trending to assess and lead all aspects of product or process performance
  • Lead and participate in the creation of risk assessments (e.g.: design and process FMEA)
  • This is a hybrid working environment that will involve remote and onsite responsibilities


Who You Are:


Basic Qualifications:


  • Bachelor’s Degree in Quality Engineering, Industrial Engineering, Chemical Engineering, Controls or other Engineering discipline OR Chemistry, Biology, or other Science discipline
  • 2+ years of Industry Experience 


Preferred Qualifications:


  • Quality Engineer or similar experience in an ISO or FDA regulated environment (such as ISO 9001, ISO 13485 or 21 CFR 820, 210 & 211)
  • Ability to conduct quality investigations including root cause analysis and determining corrective/preventative actions
  • Experience with process validation and/or equipment qualifications
  • Strong communication skills and working collaboratively intra-departmentally and with customers
  • Ability to create and update standard operating procedures (SOPs)
  • Ability to operate in a complex, matrixed, and fast-paced environment
  • Pragmatic risk-based decision-making skills with strong problem-solving ability
  • Strong computer skills including experience with relevant data analysis software tools (Minitab or JMP) and methods
  • Solid understanding of Electronic Quality Systems (CAPA, Change Control, Documentation Management)
  • Six Sigma - Green Belt or higher
  • Leadership skills
  • Life science, chemical, performance materials, or healthcare industry knowledge


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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