Job Description

The Quality Engineer in Danvers, MA, is crucial to the success of both the Quality and Manufacturing teams at our production site. Key responsibilities of the role include, but are not limited to:

• Utilize root cause analysis tools to complete product and process related investigations
• Lead and support risk assessments utilizing FMEA
• Review and improve standard operating procedures and other production documentation
• Support customer-facing improvement projects that incorporate evolving customer and industry requirements
• Conduct internal GMP and ISO audits
• Support deviation resolution in production 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

Who You Are

Minimum qualifications:

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

Preferred Qualifications:

• 1+ year of experience in Biotechnology, Pharmaceutical, Medical Device, or Life Science industries
• Lean Six Sigma and/or root cause analysis training
• Experience leading risk assessments using tools such as FMEA
• Experience with Quality Systems (e.g. Deviation, CAPA, Change Control, Documentation Management)
• Experience conducting internal/customer/supplier audits
• Demonstrated ability to write and execute test protocols and reports
• Demonstrate strong quality knowledge GMP/GDP, ISO standards