Senior Quality Engineer

 

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: 

As a Senior Quality Engineer in our Danvers, MA production site, you play a key role in the success of the Quality and Manufacturing organizations. Key responsibilities include:

• Serving as a steward for product and process quality, providing expertise for evaluation of change control for Mobius products at Danvers and across sites
• Leading and overseeing product quality investigations in conjunction with R&D, Mfg, Validation, and plant engineering, ensuring robust root cause analysis, impact and risk assessment, and corrective action implementation
• Leading execution of process improvement activities and quality improvement projects with specific focus on right first-time quality metrics, including reduction in non-conformances, reworks, and customer complaints
• Leading execution of Organization Level Agreements - Quality commitments and Quality Improvement Projects and working with stakeholders and project teams to ensure successful implementation
• Supporting customer facing improvement projects that incorporate evolving customer and industry requirements and addressing customer product related inquiries
• Support product and technology transfer activities to Mobius manufacturing sites in China and France

Weekday Shift:  Monday-Friday

 

Who You Are:

Minimum qualifications:

• Bachelor’s Degree in Engineering, Applied Engineering, Sciences or Equivalent plus 3 years of relevant and progressive work experience

Preferred Qualifications:

• Strong people leadership, project management, and problem-solving skills with a proven track record of prioritization and change management
• Basic understanding of material analysis tools and techniques i.e. FTIR, DSC Calorimetry, microscopy, particle counters, and integrity testing by pressure decay
• Detailed understanding of equipment and process validation and qualification in a regulated industry including associated toolkits i.e. p/dFMEA, statistical process control, sampling plans
• Understanding of investigations, impact assessment workflow in a regulated environment subject to time constraints. An understanding of change control process in a regulated industry
• Lean Six Sigma and/or root cause analysis training
• Experience with Quality Systems (e.g. Deviation, CAPA, Change Control, Documentation Management)
• Proven track record of working collaboratively and communicating successfully in a cross-functional and multi-cultural environment
• Demonstrate strong quality knowledge: GMP/GDP, ISO standards
• Ability to adapt and thrive in a constantly changing business environment
• Proficient in computer skills pertaining to MS Word, MS Excel, MS Powerpoint, MS Teams, MS Sharepoint to support data review, analysis and sharing

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 a