Quality Engineer

Position SummaryWe are seeking an experienced Quality Engineer III to provide advanced quality engineering support across product development, sustaining engineering, and cross-functional initiatives. This role is responsible for ensuring product and process compliance with applicable regulatory standards, risk management requirements, and internal quality systems.The ideal candidate will bring strong technical expertise, excellent communication skills, and the ability to lead quality initiatives across multidisciplinary teams in a regulated environment.Key ResponsibilitiesLead quality engineering activities throughout the product lifecycle, including design controls, risk management, and verification & validation planning.Develop, review, and maintain technical documentation such as protocols, reports, specifications, and quality records.Facilitate cross-functional meetings to align engineering teams on quality and regulatory expectations.Ensure compliance with 21 CFR Part 820, internal procedures, and applicable quality standards.Conduct and lead DFMEA / PFMEA / Risk Management activities in accordance with ISO 14971.Support Engineering Change Orders (ECO) and Engineering Change Requests (ECR) to ensure quality and regulatory compliance.Develop and support execution of Verification & Validation (V&V) strategies and studies.Partner with Operations, R&D, Manufacturing, and Quality teams to resolve quality issues and drive continuous improvement.Support root cause investigations, nonconformance management, and CAPA activities.Perform process change impact assessments and validation activities as needed.Required QualificationsBachelor’s degree in Engineering or related technical discipline.5–7 years of relevant quality engineering experience (3+ years may be considered with strong applicable experience).Strong technical writing and documentation skills.Proven experience leading cross-functional reviews and technical meetings.Solid understanding of FDA Quality System Regulations (21 CFR 820).Hands-on experience with DFMEA, PFMEA, Risk Management, and ISO 14971.Experience managing ECO/ECR processes.Experience writing and executing process validations and V&V strategies.Preferred QualificationsExperience in medical devices or other highly regulated industries.Knowledge of ISO 13485 quality systems.Operations or Sustaining Engineering support experience.Experience writing and processing NCRs.Background in Process Change Impact Assessments.Experience with CAPA and root cause analysis.Preferred Education BackgroundBiomedical EngineeringManufacturing EngineeringChemical EngineeringMechanical EngineeringOther related engineering disciplinesAdditional InformationFully onsite position in Santa Clara.Strong collaboration and leadership skills are essential for success in this role.