Software Validation Quality Engineer

Senior Software Quality Engineer (Medical Devices)Location: Brooklyn Center, MN (MECC Facility)Duration: 22-Month ContractWork Schedule: Hybrid – Onsite 4 days/weekType - W2We are seeking an experienced Senior Software Quality Engineer to support commercial medical device manufacturing. This role is ideal for professionals with a strong background in Software Validation, Computer System Validation (CSV), Process Validation, and Quality Systems within a regulated manufacturing environment.Key ResponsibilitiesProvide Software Quality Engineering support for commercial medical device manufacturing.Develop, maintain, and improve software quality standards, procedures, and validation documentation.Perform Computer Software Validation (CSV) and Process Validation activities.Review software design, change controls, verification, and validation documentation.Support CAPA, NCMR, SPC, FMEA, Root Cause Analysis, and continuous improvement initiatives.Collaborate with Engineering, Manufacturing, and Quality teams to ensure compliance with FDA and ISO regulations.Ensure product and process changes meet regulatory and customer requirements.Present technical findings and support quality improvement projects.Required QualificationsBachelor's degree in software engineering, Engineering, Computer Science, Life Sciences, or a related technical field with 4+ years of relevant experience, ORMaster's degree with 2+ years of relevant experience.Experience with Computer Software Validation (CSV) for manufacturing or production equipment.Strong knowledge of Process Validation, Change Control, and Technical Writing.Experience with CAPA, NCMR, SPC, Root Cause Analysis, and quality documentation.Working knowledge of FDA 21 CFR Part 820 (QSR) and ISO 13485:2016.Excellent analytical, communication, and problem-solving skills.Preferred QualificationsSix Sigma Green Belt (or equivalent)Experience in medical device manufacturing or other highly regulated industriesKnowledge of DOE (Design of Experiments), statistical analysis, and Risk Management (FMEA)Technical SkillsComputer Software Validation (CSV)Process Validation (IQ/OQ/PQ)Change ControlCAPA & NCMRSPCRoot Cause AnalysisFMEAISO 13485FDA 21 CFR Part 820Medical Device ManufacturingIf you have experience in Software Quality Engineering within the medical device industry and are looking for a long-term opportunity, we'd love to hear from you.