Quality Engineer II

Role: Quality Engineer II supporting quality excellence in new product development, manufacturing transfer, and commercial operations within a bioprocessing environment. Responsibilities: apply validation and design control principles per industry standards (ISO, ASME BPE, etc.); support NPI through quality tools, verify development deliverables, and maintain Design History Files; guide Design Controls and Risk Management activities, including FMEA and verification efforts; assist in developing and validating test methods; review equipment validation documentation; participate in customer complaint investigations; execute change controls and review nonconformance reports; utilize Lean and Six Sigma methodologies for continuous improvement. Requirements: Bachelor's in Biological Science, Engineering, or related; 5+ years in biotech quality engineering supporting hardware, consumables, or processes; knowledge of cell culture, filtration, chromatography; internal auditing experience; strong communication and cross-functional collaboration skills; ASQ CQE, CRE or similar certification preferred. HighValue: biotech hardware, consumables, bioprocessing, validation, Design Controls, Risk Management, ISO 9001, continuous improvement. WorkSetup: not specified; role implies collaboration across technical teams, likely in a regulated manufacturing context.