MilliporeSigma · 14 hours ago
Quality Engineer
Danvers, MA
Full-time
Onsite
Entry, Mid Level
$77K/yr - $135K/yr
1+ years expMilliporeSigma is a global leader in healthcare, life science, and electronics, dedicated to innovation and improving lives. The Quality Engineer role is critical in ensuring high-quality products reach customers by addressing complaints, conducting investigations, and leading continuous improvement projects. Responsibilities include utilizing root cause analysis, drafting reports, and ensuring compliance with regulatory standards.
BiotechnologyMedicalMedical Device
No H1B
Responsibilities
Utilize root cause analysis tools to complete product and process related investigations on customer product
Use lab techniques within a dry laboratory space to investigate returned products and perform continuous improvement projects (e.g. microscope imaging, FTIR)
Draft customer-facing reports summarizing the investigation and corrective actions for their complaints
Review and improve standard operating procedures and other production documentation
Support customer-facing improvement projects that incorporate evolving customer and industry requirements
Support complaint resolution and corrective action implementation
Assure products are manufactured in compliance with regulatory requirements and manufacturing plans are monitored for compliance to ISO, GMP, and MilliporeSigma standards
Monitor and trend process performance and drive continuous improvement
Lead projects with cross functional teams to improve in-process quality, reduce customer complaints, and increase production efficiency
Lead and support risk assessments utilizing FMEA
Conduct internal GMP and ISO audits
Qualification
Required
Bachelor's Degree in Mechanical Engineering, Chemical Engineering, or other Engineering discipline OR in Biology, Chemistry, or other Life Science discipline
Preferred
1+ year of experience in Biotechnology, Pharmaceutical, Medical Device, or Life Science industries
Experience with technical writing
Experience with Excel and Word software
Experience utilizing Microsoft Excel for data analysis
Experience with TrackWise and/or Veeva Quality software or other Quality Systems
Lean Six Sigma and/or root cause analysis training
Experience leading risk assessments using tools such as FMEA
Experience conducting internal/customer/supplier audits
Demonstrated ability to write and execute test protocols and reports
Demonstrated strong quality knowledge: GMP/GDP, ISO standards
Benefits
Health insurance
Paid time off (PTO)
Retirement contributions
Other perquisites
Company
MilliporeSigma
Together with our colleagues, customers and stakeholders, we impact life and health with science.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
David Nogales
Head of Technology Strategy
Recent News
2025-09-23
2025-06-20
Company data provided by crunchbase