Design Controls and Risk Management Quality Engineer (ISO 9001)

Job Description

Job Description Design Controls and Risk Management Quality Engineer (ISO 9001)

Engagement: 6‑month contract | Location: Marlborough, MA | Compensation: $50–$57 per hour

Role snapshot

• Operate within an ISO 9001:2015 QMS to support new product development, manufacturing transfers, and commercial manufacturing.
• Provide specialized Quality Engineering leadership on hardware devices and consumables for biotech applications.
• Ensure adherence to validation and design control requirements aligned to Quality ISO standards, ASME BPE, CE, BPOG, and REACH.

Key contributions

• Partner with NPI teams to deploy Quality Engineering tools that accelerate development, transfer, and lifecycle maintenance.
• Verify design deliverables and assemble complete, audit‑ready Design History Files (DHFs).
• Lead risk management activities (FMEA) and plan/execute design and process verification.
• Develop and validate test methods demonstrating product and process performance.
• Review equipment IOPQs supporting commercial operations.
• Execute change controls; organize and run change control review board meetings.
• Review/approve, when required, nonconformances, deviations, investigations, and corrective action plans prior to release.
• Support customer complaint investigations as needed.
• Apply Lean and Six Sigma methodologies to improve capability and reduce variation.

Qualifications

• BA/BS in Biological Science, Engineering, or Physical Science.
• 3–5 years as a Quality Engineer within an ISO 9001 QMS (or comparable system).
• Hands‑on New Product Development Quality Engineering experience.
• Background with biotech hardware/consumables and related manufacturing processes.
• Understanding of cell culture, filtration, and chromatography in bioprocessing.
• Internal auditing experience.
• ASQ Certified Quality Engineer (CQE), CRE, or equivalent preferred.
• Exceptional organization, ability to prioritize and multitask, strong judgment, and practical problem‑solving.

What success looks like

• On‑time DHFs with complete, traceable design control artifacts.
• Risk controls identified early and verified through robust test methods.
• Smooth manufacturing transfers with verified processes and documented IOPQs.
• Effective change control governance and timely closure of investigations and CAPAs.