Quality Engineer

The businesses of Merck KGaA, Darmstadt, Germany•Danvers, MA

11h

About The Position

The Quality Engineer position in Danvers, MA, is crucial in addressing customer complaints and ensuring high quality product reaches our customers. Key responsibilities of the role include, but are not limited to: 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

Requirements

Bachelor’s Degree in Mechanical Engineering, Chemical Engineering, or other Engineering discipline OR in Biology, Chemistry, or other Life Science discipline

Nice To Haves

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

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