NPI Quality Engineer

Posted 09 Sep 2019

Burlington, Massachusetts - United States

Req Id 197433


A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 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:

Quality representative on new Product Development Projects for the 3rd party finished goods plant. Ensure a single voice of Quality by assuring collaboration and alignment with R&D, Site Quality, Supplier Quality and/or Services Quality. Ensure the team members are adhering to the established product & process development program. Responsible for planning, committing to, and fulfilling the goals of the project. Ensure that the right quality activities and durations are defined on the project plan and accurately maintained throughout the project. Responsible for participating in project risk management including the identification, classification, and mitigation of risk. Author project’s Validation Master Plan and participate in detailed planning of product and process validation. Provide framework and direction for Failure Mode and Effects Analysis (FMEA) process; Ensure completion of FMEAs (Design, Process, Applications), Hazard Analysis and Medical Device Risk Assessment (if applicable), and associated action items. Coordinate completion of Supplier Assessment. Verify product claims are accurate, substantiated and consistent across Regulatory Assessment, Product Description, Certificate of Quality, labeling, user guides, product inserts, validation guides, performance guides, data sheets, application notes, and technical briefs. 

Who You Are:

Basic Qualifications:

• A minimum of 6 years Quality Engineering experience in FDA regulated industry (medical device, pharmaceutical or biotechnology)

• Bachelors of Science degree in Engineering, Life Sciences, or related field or equivalent in combination of experience and education.

• Capable of effectively managing multiple projects.

• Experience with new product development.

• Experience utilizing Root Cause Analysis and risk assessment tools is required (FMEA)

• Experience utilizing statistical analysis techniques

• Knowledgeable in ISO and GMP

Preferred Qualifications:

• Self-directed and self-motivated

• ASQ Certified Quality Engineer (CQE).

• Excellent communication skills and demonstrated ability to work with diverse functional groups.

• Supplier Quality Management experience

• Some travel required (5-10%)

• Excellent technical writing and verbal communication skills in English

• Detail oriented with strong analytical and problem solving skills

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

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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