Quality Engineer I

Job Description

Job Description

Quality Engineer I Pharma and Medical Device

Contract 12 months (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

Lead and maintain validation, calibration, and environmental monitoring programs.

Conduct internal and supplier audits to ensure compliance with ISO and FDA standards.

Investigate deviations and complaints using root cause analysis and risk assessment tools.

Review quality metrics, trend reports, and SOPs to ensure continuous improvement.

Support customer, regulatory, and internal audits.

About You

Bachelor's in a life science (Chemistry, Biology, Microbiology, or related).

3–5 years of relevant experience in quality systems within regulated industries.

Strong communication, organization, and problem-solving skills.

Experienced in investigations, audits, and quality documentation.

CQE / CQA certification preferred.