New Product Introduction Quality Engineering Manager

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

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

Location:

The New Product Introduction Quality Engineering Manager is an on-site role in Burlington, MA with 10%domestic and international travel required for business.

Your Role:

As the NPI Quality Engineering Manager at MilliporeSigma, you will lead and manage the NPI quality engineering team while also serving as an NPI quality engineer.  In this dual role, you will represent the NPI quality engineering group in new product development and buy-resell projects for our external manufacturing partners.

Key Responsibilities:

• Oversee the development and performance of the NPI quality engineering team.
• Monitor and maintain training programs to achieve required metrics and performance standards.
• Ensure that all procedures are accessible, accurate, well-understood, and followed by NPI quality engineers and project teams.

• 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.
• Participate 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:

• Bachelor’s Degree in Engineering, Life Sciences or similar discipline with 5+ year of quality engineering experience in a medical device, pharmaceutical, biotechnology, or related life science industry.  Or experience and/or knowledge gained thru work experience (typically >8 yrs) in lieu of a degree.
• Working understanding of New Product Introduction process in an a medical device, pharmaceutical, biotechnology, or related life science industry

Preferred Qualifications:

• Capable of effectively managing quality engineers.
• Capable of effectively managing multiple projects.
• Experience with new product development or Supplier Quality Management.
• Experience utilizing Root Cause Analysis and risk assessment tools (FMEA)
• Experience utilizing statistical analysis techniques
• Knowledgeable in ISO and GMP
• Self-directed and self-motivated
• Excellent communication skills and demonstrated ability to work with diverse functional groups.
• Excellent technical writing and verbal communication skills  
• Detail-oriented with strong analytical and problem-solving skill

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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

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