Quality Engineer

Posted 14 Dec 2021

Danvers, Massachusetts - United States

Req Id 235428

Details

 

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 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.

 

 

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of fully vaccinated assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

 


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.  

 

  • (50%) 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.
  • (50%) Daily Activities – Technical Writing / Root Cause Analysis
    • Work with the Complaint Engineering team to resolve customer complaints through investigations, root cause analysis, and developing corrective and preventative actions.
    • Perform root cause analysis
    • Manage cross functional teams to determine root cause and corrective actions.
    • Work with manufacturing, engineering, and other groups to identify potential root causes.
    • Investigate technical drawings, standard operating procedures, processes, and other potential causes of complaints.
    • Facilitate clear communication between teams during root cause analysis.
    • 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.
    • Write customer facing investigation reports
      • Summarize lab investigation, root cause, and corrective actions into a final customer facing letter.

 

 

Who You Are:

 Basic Qualifications:

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

 

Preferred Qualifications:

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

RSRMS


 

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Our Benefits - http://jobs.vibrantm.com/emd/content/Benefits-at-a-Glance/?locale=en_US

Curious? Apply and find more information at https://jobs.vibrantm.com

If you are a resident of a 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.

 

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