Manufacturing Transfer Quality Engineer — Biotech Hardware & Consumables

Term: 6‑month contract | Where: Marlborough, MA | Rate: $50–$57/hour

Why this matters

Are you energized by launching reliable biotech hardware and consumables that scientists trust every day? In this role, you’ll be the quality voice from concept through commercialization—ensuring designs meet requirements, risks are controlled, and processes are verified under an ISO 9001:2015 Quality Management System.

Your mission

1. Champion design controls and validation principles aligned with Quality ISO standards, ASME BPE, CE, BPOG, and REACH.
2. Embed Quality Engineering practices in NPI to enable efficient development, transfer, and lifecycle maintenance.
3. Own risk management (FMEA) and lead design/process verification to confirm requirements are met.
4. Build audit‑ready DHFs and confirm completeness of new product development deliverables.
5. Develop/validate test methods that objectively demonstrate product and process performance.
6. Review equipment IOPQs supporting commercial operations.
7. Run effective change controls, including facilitating change control review board meetings.
8. Review and approve, when required, nonconformances, deviations, failure investigations, and corrective action plans prior to implementation.
9. Contribute to customer complaint investigations as needed and drive continual improvement via Lean and Six Sigma.

What you’ll need to succeed

• Bachelor’s degree in Biological Science, Engineering, or Physical Science.
• 3–5 years of Quality Engineering experience within an ISO 9001 QMS (or equivalent).
• Demonstrated New Product Development Quality Engineering experience.
• Direct experience with biotech hardware and consumables manufacturing processes.
• Fundamentals in bioprocess operations: cell culture, filtration, and chromatography.
• Internal auditing experience.
• ASQ CQE, CRE, or similar certification preferred.
• Outstanding organization, the ability to prioritize and multitask, and strong problem‑solving with sound judgment.

Imagine the impact

Three months in, a new device is ready for verification. Because you developed robust test methods, tightened risk controls via FMEA, and ensured complete DHF traceability, the team navigates transfer with confidence—processes verified, IOPQs reviewed, change controls documented, and the product delivered to manufacturing on schedule.