Quality Engineer

Posted 09 Jan 2023

Sheboygan Falls, Wisconsin - United States

Req Id 259806

 

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/requirements 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 require remote and onsite responsibilities

 

 Physical Attributes

  • View computer monitors for long periods of time.
  • Regularly uses phones, computers, computer monitors and office/laboratory equipment.

 

Who You Are:

 

Basic Qualifications:

 

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

 

Preferred Qualifications:

 

  • Quality Engineer or similar experience in an ISO or FDA regulated environment
  • Understanding or experience with ISO & FDA regulations (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
  • Excellent organizational, written & verbal communication, and interpersonal skills
  • Ability to create and update standard operating procedures ("SOP")
  • Ability to operate in a complex, matrixed, and fast-paced environment
  • Pragmatic risk-based decision-making skills with strong problem-solving ability
  • Collaborative and motivated teammate. Always looking to share and advance best practices
  • 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 Black Belt
  • Leadership skills
  • Strong computer 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


Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure

If you are a resident of Colorado or New York City, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html

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