Quality Engineer

Posté 11 mai 2022

Danvers, Massachusetts - United States

Demander un identifiant 247362



A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

At MilliporeSigma, Quality Engineering is part of the customer complaint engineering team which is a sub-team of the Quality Systems group at the Danvers manufacturing site.  

  • (75%) Daily Activities – Lab Analysis
    • Perform hands on analysis of returned customer complaints. This includes 0 – 3500L single use bags, tube sets, and other single use components.
    • Perform leak testing through use of air and water, confirmation of specifications, confirmation of accuracy compared to manufacturing drawings, and visual analysis (microscopic and camera images).
    • Assist in initial root cause analysis.
    • Write an investigation report for each complaint analyzed.
  • (25%) Daily Activities – Root Cause Analysis / Continuous Improvement
    • Work with the Complaint Engineering team to resolve continuous improvement projects and perform in-depth analyses into root causes.
    • Participate in cross functional teams to determine root cause and corrective actions.
    • Work with manufacturing, engineering, and other groups to identify potential root causes.
    • Observe manufacturing operations in the clean room to assess contributing factors of issues that arise.
    • Work with manufacturing, engineering, other departments to develop an effective corrective action plan.
    • Identify potential improvements based on the manufacturing process and operator behavior.


 Who You Are:

Minimum Qualifications:

  • 1+ years background with manufacturing or Quality Control at Danvers, MA MilliporeSigma facility


  • Bachelor’s Degree in Mechanical, Biomedical Engineering, Plastics, Chemical or related discipline


Preferred Qualifications:

  • Experience using Root Cause Analysis tools
  • Demonstrated ability to work with cross-functional groups
  • Must be able to multi-task and prioritize activities
  • Self-directed and self-motivated
  • Excellent communication skills
  • Knowledgeable in ISO 9001 and/or GMP
  • Experience with technical writing
  • Experience with Excel and Word software
  • 1+ year's Engineering experience in FDA-regulated industry (pharmaceutical, biotechnology or medical device) or in life science industry


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. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!


Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com


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


If you are a resident of NYC, Connecticut or Colorado, 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.


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.


As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.