Senior Quality Engineer (Membrane Facility)

 

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:

 

The Senior Quality Engineer (Membrane Facility) at MilliporeSigma in Sheboygan Falls, WI will be part of our new, state-of-the-art membrane facility and will support the transfer of methods and processes from our Cork, Ireland facility. The Quality Engineer will coordinate key quality initiatives for the new facility and provide overall quality assurance support for on-site manufacturing. Daily tasks and responsibilities will include the following: 

 

• Schedule and facilitate cross-functional meetings to implement key quality system elements including, but not limited to Customer Notifications, Complaints, Deviations/CAPAs, Supplier Management, Data Integrity, Document and Record Control, Training Program, and product support functions supported by Quality Systems 
• Perform risk assessments 
• Aid the transfer of product specifications and perform and oversee test result reviews of raw materials, in-process and final product sample inspections 
• Work with Quality Control to coordinate product stability studies 
• Provide input and support on the validation process, including review and approval of validation plans, protocols, and reports 
• Assist membrane pre-qualification 
• Make usage decisions  
• Support the release, storage, distribution, returns and destruction of materials 
• Perform quality checks and support the data integrity program 
• Write and review documentation to ensure compliance with company and customer quality requisites 
• Prepare and participate in audits (customer, regulatory/certifying body) 
• Support or facilitate customer-facing meetings to meet quality expectations 
• Shift/Hours: 8:00 AM -5:00 PM, Mon-Fri 

 

Who You Are: 

 

Minimum Qualifications: 

 

• Bachelor’s degree in engineering, quality, chemistry, or other scientific discipline and 3+ years of experience in a Quality role  

      OR  

• Master’s degree in engineering, quality, chemistry, or other scientific discipline and 1+ year of experience in a Quality role  

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Preferred Qualifications:

 

• Knowledge of ISO 9001; ISO 14001; ISO 13845; GMPs 
• Knowledge of electronic Quality Management Systems (TrackWise, ManGo, etc.) 
• Ability to conduct quality investigations including root cause analysis and determine corrective and preventative actions 
• Strong technical skills including the ability to interpret and evaluate information submitted by technical (analytical) specialists 
• Familiar with integrated and automated operations systems, e.g., MES (Manufacturing Execution System)  
• Enthusiastic, flexible, and highly motivated 
• Excellent problem-solving skills 
• Highly detail-oriented and well-organized 
• Strong oral and written skills, including excellent presentation skills 
• Ability to work independently in a fast-paced, team environment 
• Life Science, chemical, 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