Engineer I, Quality (THV)

Job TitleEngineer, Quality (THV)Role LevelIndividual ContributorSupervisor/Manager TitleSenior Manager, Quality EngineeringJob Location & EnvironmentIrvine, CA - Corporate office / Controlled Cleanroom EnvironmentJob Description SummaryProvide regular Quality Engineering support to transcatheter Heart Valve (THV) manufacturing and relevant areas including design verification and validation, production line/receiving inspection support, process validation (IQ/OQ/PQ), process optimization, non‑conformance identification/initiation/investigation, risk management, and post‑market assessment.Job ResponsibilitiesPartner with Manufacturing Engineers to characterize and qualify manufacturing processes.Provide technical quality support to ensure new processes/procedures comply with governing standards and procedures.Review documentation and production records to ensure all products are produced in compliance with QSRs and ISO standards and that all Device History Records (DHR) are complete, accurate and compliant with Good Documentation Practice (GDP).Review and update Device Validation Master Plan (VMP).Create and approve test protocols and reports in support of equipment qualifications (IQ/OQ/PQ), design verification, continuous improvement projects, validation activities and Gage R&R studies.Create and review technical reports and documentation.Support or lead root cause analysis investigations for production‑related or quality‑related nonconformities and develop and aid in the implementation of corrective actions.Develop and implement effective corrections/corrective actions.Partner with R&D and Manufacturing Engineers to develop/refine critical manufacturing processes.Function as a core‑team member in cross‑functional teams in the generation and implementation of improvement projects and process scale‑up projects.Audit the manufacturing line to ensure compliance to governing procedures is being met.Support internal and external (supplier) audits.Support elements of the quality system such as, but not limited to, NCRs, CAPAs and complaints.Required Education and ExperienceBachelor of Science degree in engineering or a relevant scientific subject required; biomedical, biochemical or chemical degree preferred.Minimum 2 years of medical device quality/ regulatory experience in a medical device, pharmaceutical or life sciences technology‑driven company; Level I, II, III DOE.Experience with nonconformances, investigations, root cause analysis, risk analysis and corrective/preventive actions.Familiarity with 21CFR820, ISO 13485 and ISO 14971 requirements.Skills And AbilitiesAdhere to company code of conduct and contribute to a professional, collaborative and respectful team‑working environment.Work effectively in a regulated manufacturing/cleanroom environment.Strong attention to detail while reviewing documents and records.Identify work priorities and deploy resources to ensure business needs are met.Collaborate effectively within cross‑functional teams.Articulate results and conclusions both verbally and in writing to technical and non‑technical personnel.Handle multiple tasks with high attention to detail.Physical RequirementsMinimum traveling, less than 10%, required for tooling development and testing.Work in a manufacturing, laboratory, and cleanroom environment, including compliance with applicable gowning and PPE requirements.Follow clean room, laboratory, and site safety protocols at all times.May require use of inspection and testing equipment as needed.#J-18808-Ljbffr