Professional Responsible for Medical Device Validation

Senior Validation Engineer We are seeking a highly experienced Senior Validation Engineer to join our team in Santa Clara, CA. This role focuses on the validation of components, processes, and suppliers within the medical device industry. The ideal candidate will have a strong background in IQ, OQ, and PQ protocols, as well as experience with tools such as ADAPTIV, SQA, SQS, FLI, and FAI. Prior experience in regulated environments is highly preferred. Key Responsibilities: Lead and execute validation activities (IQ, OQ, PQ) for components, manufacturing processes, and supplier qualifications. Collaborate with cross-functional teams to ensure compliance with FDA and ISO standards. Utilize tools such as ADAPTIV for documentation and validation tracking. Support and coordinate with Supplier Qualification Agreement (SQA), Supplier Qualification System (SQS), First Lot Inspections (FLI), and First Article Inspections (FAI). Prepare and review validation protocols, reports, and risk assessments. Ensure timely execution of validation deliverables in alignment with project timelines. Participate in audits and regulatory inspections as a subject matter expert. Basic Qualifications: Bachelor's degree in Engineering or a related technical field. 5+ years of experience in validation engineering within the medical device industry. Strong knowledge of IQ, OQ, PQ methodologies and regulatory requirements. Intermediate knowledge of statistics. Experience with ADAPTIV, SQA, SQS, FLI, and FAI processes. Advanced or bilingual proficiency in English. Valid tourist visa and eligibility to apply for a TN Visa. Strong analytical, documentation, and communication skills. Ability to work on-site in Santa Clara, CA.

Creado: Jue, 01 de Ene de 1970