Quality Engineer - Design Assurance

Posted 24 Jan 2020

Danvers, Massachusetts - United States

Req Id 202152



A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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:

The Quality Engineer - Design Assurance, will be responsible for providing quality assurance support for the development and introduction of new MilliporeSigma products and solutions. As a core team member of product development teams, you will be ensuring the timely delivery of quality products to market. You will also be responsible for seeing that MilliporeSigma is compliant with its quality system and design controls. This position reports to the Head of Quality at the Danvers, MA site.

  • Provide expert design assurance guidance and support for MilliporeSigma product, program, and solution development projects. Responsibilities to include:
  • Design control
  • Product and process validation planning and support
  • Risk management
  • Supplier assessments
  • Interface and coordinate activities with other quality functions such as manufacturing site quality, quality systems, regulatory affairs, external quality groups, etc…
  • Interface with and leverage the entire matrix organization at MilliporeSigma in order to best achieve organizational goals.


Who you are:

Basic Qualifications:

  • 1+ years progressive, seasoned design assurance engineering within the biopharma or medical device industries
  • Bachelor's degree in related technical area (preferably engineering)
  • Full understanding of product and process validation
  • Demonstrated capability of applying risk management concepts and tools
  • Hands-on experience in the application of quality system standards
  • Experienced at working in cross-functional teams
  • Other necessary expertise:
    •       Design control
    •       Knowledge of quality and regulatory requirements
    •       Development of solutions to complex problems
  • Must be able to multi-task and prioritize activities
  • Strong written and verbal communication skills (internal/external)
  • Strong teamwork and collaboration skills
  • Strong organizational skills
  • Willingness and ability to travel to MilliporeSigma’s suppliers or internal customer locations


Preferred Qualifications:

  • Other Desirable expertise:
    • ASQ Quality Engineer Certification (CQE)
    • Six Sigma Certification
    • Quality by Design
    • Applied/industrial statistics experience
    • GAMP5


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!

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

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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