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MilliporeSigma · 2 days ago

Quality Engineer

Danvers, MA

Full-time

Onsite

Entry Level

$67K/yr - $123K/yr

1+ years exp

MilliporeSigma is a global leader in science and technology, committed to enriching lives through innovative solutions in Healthcare, Life Science, and Electronics. The Quality Engineer role is essential for the Quality and Manufacturing teams, focusing on ensuring compliance with regulatory standards and driving continuous improvement in process performance.

BiotechnologyMedicalMedical Device

No H1B

Responsibilities

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

Qualification

Root cause analysisFMEAGMP/GDP knowledgeLean Six SigmaQuality Systems experienceInternal auditsTest protocols writingCross functional teamwork

Required

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