Job Description
Job Description
Quality Engineer I Pharma and Medical Device
Contract 25 weeks (could extend)
No visa sponsorship for this role
Schedule: 1st Shift | 8:30 AM 4:30 PM | Some flexibility
Work Location: Onsite- Devens, MA, 01434
Summary
My client is looking for a skilled Quality Engineer to help ensure systems and processes meet both company and regulatory standards. This role is key in maintaining high product quality and supporting continuous improvement initiatives across departments.
Why You Should Apply
You'll play a hands-on role in shaping quality systems, leading audits, and driving root cause analysis in a collaborative environment that values accuracy, compliance, and innovation.
What You'll Be Doing
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Lead and maintain validation, calibration, and environmental monitoring programs.
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Conduct internal and supplier audits to ensure compliance with ISO and FDA standards.
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Investigate deviations and complaints using root cause analysis and risk assessment tools.
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Review quality metrics, trend reports, and SOPs to ensure continuous improvement.
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Support customer, regulatory, and internal audits.
About You
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Bachelor's in a life science (Chemistry, Biology, Microbiology, or related).
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3–5 years of relevant experience in quality systems within regulated industries.
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Strong communication, organization, and problem-solving skills.
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Experienced in investigations, audits, and quality documentation.
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CQE/CQA certification preferred.