Sr Design Quality Engineer (Consumables)
Core
Provides design quality engineering guidance and support for New Product Introduction (NPI) and Product Life Cycle Management (LCM) of life science products (electro-mechanical devices, biocides, detergents, biological indicators) ensuring compliance with Quality Management Systems and regulatory requirements.
Role type
Senior IC Quality Engineer (Design & Regulatory)
Builds
Risk management processes, design verification and validation documentation, and quality control plans for sterilization and disinfection solutions.
Domain
Life Sciences / Medical Devices / Sterilization Technology
Required skills
Risk Management, Design Control, Design Verification and Validation, Root Cause Analysis, FMEA, Statistical methodologies, Regulatory compliance (FDA QSR 21 CFR 820 / ISO13485), Cross-functional collaboration, Project management, Technical communication
Preferred skills
6-Sigma, Lean, Method validation, Microbiological method validation, Manufacturing equipment knowledge
Technologies
Microsoft Excel, Word, PowerPoint, Statistical analysis tools
Responsibilities
Own the Risk Management process and facilitate risk analyses; Perform complex technical investigations including formal NCs and CAPAs; Provide training and guidance on quality management system elements; Identify and recommend improvements to quality systems using 6-Sigma and Lean; Participate in cross-functional projects and lead small projects; Support internal, external, and third-party audits as a Quality Subject Matter Expert; Interface with regulatory agencies or customers during audits.
Seniority
Senior, hands-on IC