Engineer II, Quality

Role: Quality Engineer II supporting manufacturing and engineering operations for medical devices, ensuring compliance and high quality. Responsibilities: own investigations, nonconformance management, CAPAs, and validation support; lead risk assessments and process improvements; support new product transfers and regulatory audits; collaborate with cross-functional teams across manufacturing, engineering, and quality. Requirements: Bachelor's in Engineering or Life Sciences; 3+ years in Quality Engineering within regulated manufacturing, preferably medical devices; knowledge of FDA QSR, ISO 13485, ISO 9001, cGMP, and risk management (ISO 14971); experience managing investigations, CAPAs, validations, and data analysis using statistical tools like SPC or Minitab; proficiency with QMS, ERP, and documentation. Preferred: CQE certification, TrackWise Digital experience, cleanroom manufacturing. HighValue: medical device manufacturing, compliance with FDA/ISO standards, validation, risk management, cross-functional collaboration. WorkSetup: on-site.