Quality Engineer I

Posté 19 mai 2022

Jaffrey, New Hampshire - United States

Demander un identifiant 249056

Détails

 

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.


Your role: 

We are looking for a Quality Engineer to join our team supporting the QC Labs in Jaffrey, NH. The world-class Jaffrey Manufacturing Center of Excellence is ISO 9001 and ISO 14001 Certified, practices Six Sigma principles and is an environmentally conscious facility focused on long term sustainability. 

  • Provide guidance and support for the QC Labs. This includes the evaluation of deviations / out of specification conditions, data trending, and leading quality investigations (root cause analysis and corrective action plans)
  • Provide guidance and support for product and process changes by working with the cross functional team to determine the implantation requirements based on applicable industry standards and regulations
  • Provide guidance and support for product validation and equipment qualifications including establishing acceptance criteria, sampling plans and performing data analysis.
  • Write validation protocols and reports
  • Create / Revise Standard Operating Procedures, Test Methods and other documents.
  • Perform statistical analysis and trending to assess and monitor product/process performance
  • Provide guidance for the disposition of non-conforming product and raw materials.
  • Lead and participate in the creation of risk assessments and change control system (e.g. product and process-FMEA)
  • Provide guidance and support for shelf life studies both accelerated and real-time aging. Including protocol creation, sample submission, data analysis, out of specification investigation, and report creation
  • A Shift: Monday - Friday 8 AM - 4 PM

 Who you are:

 Minimum Qualifications:

  • Bachelor of Science degree
  • 2+ years Quality Engineering or experience in FDA regulated (pharmaceutical, biotechnology, or medical device) environment

 Preferred Qualifications:

  • Bachelor of Science degree in Engineering
  • Knowledge in ISO & FDA regulations (such as 21 CFR 820, 210 & 211)
  • Ability to conduct quality investigations including root cause analysis and determining corrective / preventative actions, Pragmatic risk-based decision maker with strong problem-solving ability
  • Demonstrated ability to create and update standard operating procedures ("SOP")
  • Validation experience in a regulated industry
  • Strong communication skills with the ability to collaborate at all levels and functions of the organization and with customers, operate in a complex, matrixed, and fast paced environment and gain consensus with groups
  • Collaborative and motivated team player. Always looking to share and advance best practices
  • Experience with relevant data analysis Software / Tools (Minitab) and Methods, working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management)
  • ASQ CQE, Green Belt or Black Belt

RSRMS

 

 

 


 

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.

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