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Quality Engineer II (Biotech)
Engineering
Marlborough, Massachusetts, US
- Added - 02/03/2026
Our client is a leading life sciences company that develops and manufactures tools and materials used in the production of biologic drugs. They are looking for a skilled Quality Engineer II to join their growing team In Middlesex County, MA! This is a great opportunity to contribute to an innovative life science organization!
Job Summary:
The Quality Engineer II will actively contribute to the company’s QMS by supporting new product development, manufacturing transfer activities, and ongoing commercial product operations. This role ensures product and process quality through validation, risk management, and adherence to regulatory standards.
Job type: 6-month contract (possibility of extension or conversion)
Pay rate: $53 - $55/hr.
Location: Middlesex County, MA
Key Responsibilities
- Implement and maintain Validation Principles, Design Controls, and regulatory compliance (e.g., ISO standards, ASME BPE, CE, BPOG, REACH).
- Support New Product Introduction (NPI) by deploying Quality Engineering tools to streamline development, transfer, and lifecycle management.
- Work with cross-functional teams to verify product development deliverables and compile Design History Files for product release.
- Conduct Design Controls & Risk Management activities, including FMEA, Design Verification, and Process Verification.
- Assist in development and validation of test methods for product and process performance.
- Review and approve Equipment Installation, Operational, and Performance Qualifications (IOPQ) for commercial operations.
- Participate in customer complaint investigations and implement corrective actions.
- Execute change controls, chair Change Control Review Board meetings, and manage nonconformances, deviations, and failure investigations.
- Apply Lean and Six Sigma methodologies to drive process improvements.
Qualifications:
- BA/BS in Biological Science, Engineering, or Physical Science.
- Minimum 3–5 years as a Quality Engineer in ISO 9001 QMS or equivalent.
- Hands-on experience in New Product Development Quality Engineering for biotech hardware and consumables.
- Basic understanding of cell culture, filtration, and chromatography in bioprocessing.
- Experience with internal auditing.
- Certifications (preferred): ASQ Certified Quality Engineer (CQE, CRE) or equivalent.
- Strong organization, multitasking, and prioritization.
We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
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Quality Engineer II (Biotech)