NPI Quality Engineer

JobsCloseBy Editorial Insights

Merck Group is hiring an NPI Quality Engineer to support New Product Introduction at the Jaffrey NH site, a ISO 9001 and ISO 14001 certified facility committed to Six Sigma and sustainability. You will partner with Product Development and Product Management to launch new products, serve as the quality engineering liaison for device manufacturing, lead risk assessments including product and process FMEAs, guide validations and equipment qualifications, write validation protocols and SOPs, analyze data for trends, and direct investigations of nonconforming materials and shelf life studies. Requirements: BS in engineering and 3+ years in quality in a regulated setting, working knowledge of ISO 9001:2015; preferred: MS, 5+ years in FDA regulated environments, strong cross functional communication, validation and RCA/CAPA experience, Minitab and electronic quality systems, CQE or Six Sigma. Onsite in Jaffrey, no sponsorship; salary range $80k-$138.1k plus benefits. Tips: tailor resume to FMEAs, validations, SOP writing, data analysis, and cross functional impact; show matrixed, fast paced collaboration and problem solving.

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. 

Your Role

We are seeking a NPI Quality Engineer to join our team supporting New Product Introduction 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.

• Collaborate with Product Development and Product Management on the introduction of new products and/or line extensions into the Jaffrey facility.
• Provide Quality Engineering guidance and support for device manufacturing as a liaison between product development and the plant.
• Lead and participate in the creation of risk assessments (e.g. product and process-FMEA).
• Provide guidance and support for product validations and equipment qualifications including establishing acceptance criteria, sampling plans and performing data analysis.
• Writes and approves validation protocols and reports, creates and updates SOPs and test methods, and performs data analysis and trending to monitor product quality and process performance.
• Provide guidance for the disposition of non-conforming product and raw materials. 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 shelf-life studies both accelerated and real-time aging including protocol creation, sample submission, data analysis, out of specification investigation, and report creation.

Who You Are

Minimum Qualifications

• Bachelor of Science degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering or other technical discipline
• 3+ years of Quality Engineering experience or similar technical role in a regulated manufacturing environment

• Working Knowledge of ISO 9001:2015 requirements

Preferred Qualifications

• Master’s degree in Mechanical Engineering, Chemical Engineering Industrial Engineering or other Engineering discipline.
• 5+ years of Quality Engineering experience in an FDA regulated (pharmaceutical, biotechnology, or medical device) manufacturing setting with proven track record of successful performance.
• 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
• Validation experience in a regulated manufacturing industry.
• Conduct quality investigations including root cause analysis and determining corrective / preventative actions.
• Pragmatic risk-based decision maker with strong problem-solving ability.
• Collaborative team player with experience using data analysis tools such as Minitab, electronic quality systems (CAPA, Change Control, and Document Management), and continuous improvement methodologies, including ASQ Certified Quality Engineer (CQE) and Six Sigma Green Belt/Black Belt practices.
• Demonstrated ability to create and update standard operating procedures ("SOP")

Pay Range for this position: $80,000.00 -$138,100.00 annually

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.  

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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 a team that is dedicated to Sparking Discovery and Elevating Humanity!