Quality Assurance Specialist

Posted 19 Dec 2022

Sheboygan Falls, Wisconsin - United States

Req Id 259306


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:


As a Quality Assurance Specialist for MilliporeSigma in Sheboygan Falls, WI, you would support the development, maintenance and improvement of quality systems and ensure their alignment with business goals, premier customer expectations/requirements and global business unit best practices. Duties within the scope of this description are focused on quality system development and maintenance, quality deployment activities including preparation, participation, and hosting customer audits, reporting for internal and external customers, employee training, change management, and supply chain management/qualification.  Leading quality initiatives and providing support for internal review teams and selected supplier audits.


Key Accountabilities:

  • Managing customer complaints including determining root cause, identifying trends and tendencies with respect to lot, product, and recommends change based on investigation and trend analyses
  • Managing changes by assisting in the evaluation and ensuring that deliverables are compliant with customer and corporate requirements
  • Ensure customer satisfaction by assisting in completion and review of required customer documentation
  • Involvement in quality activities geared towards procedural and system improvements through review and approval of product quality failures, noncompliance investigations, and implementation of best-known practices
  • Assistance with the preparation and participation in internal and external audits.
  • Ensuring quality through monitoring system compliance to regulatory, company, and industry standards, and focusing on quality system definition and continuous improvement.
  • Coordinate and lead key quality initiatives
  • As applicable, facilitate or support customer facing meetings to maintain customer requirements
  • Perform statistical analysis and reviews
  • Perform other duties as assigned to support the advancement of quality systems and operations and meet the quality expectations of premier customer base
    • Enhancing Quality System elements to meet key customer expectations
    • Performing annual product reviews
    • Participating in Material Review Board support functions
    • Preparing and participating in customer audits
    • Preparing and participating in supplier audits and qualification activities including dual sourcing initiatives
    • Facilitating investigations for Quality notifications / Corrective actions
    • Customer Change Control liaison
    • Participating in Failure Mode and Effects Analysis
    • Use knowledge and experience to support internal audits
  • Write and/or review documentation to ensure compliance to company or customer quality requirements
  • Provide quality awareness training for site employees
  • Prepare reports for local management and customers


Who You Are:


Minimum Qualifications:

  • Bachelor’s Degree in any discipline
  • 3+ years of experience in the specific Quality Assurance job function
  • 3+ years in a Quality Control, Production, or Project Management position
  • 3+ years of experience in hosting and performing internal and external audits


Preferred Qualifications:

  • Previous demonstrated leadership ability, including the ability to correctly evaluate
    the facts and unforeseen situations in order to make the best decisions
  • Bachelor of Science degree in Chemistry, Chemical Engineering, or other Life Science
  • Excellent communication skills both verbal and written, including proficiency in
    negotiation and persuasion
  • Understanding of Quality System Regulations, ISO Quality Systems, and other FDA
  • Strong computer skills, including proficiency in MS Word, MS Excel, MS Access, MS
    PowerPoint, Google, and ERP systems
  • Understanding of data analysis, presentation, and experimental design
  • Understanding of current processing requirements for electronic, drug, industrial,
    and biologic types of products
  • Excellent problem-solving skills/abilities with the ability to implement relevant
    solutions to problems or situational changes
  • Good time management skills
  • Ability to increase efficiencies in the continuous improvement of the quality
    management system
  • Good team player
  • Enthusiastic and flexible
  • Agent for change and improvement
  • Ability to work independently and in a fast-paced, team environment
  • Knowledge of SAP


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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