QA Specialist

Job Title: Quality Assurance Specialist (QA Specialist)

Location: Santa Clara, CA

Duration: 6 Months

Industry: Medical Device (Preferred)

Experience: 2–4 YearsJob Summary

We are looking for a Quality Assurance Specialist with 2–4 years of experience to support quality system activities and maintain Design History Files (DHF) documentation. The ideal candidate will have experience in a regulated environment and a basic understanding of design controls and quality processes.ResponsibilitiesMaintain and review Design History Files (DHF) and quality documentation.Support document control and change control activities.Assist with CAPA, nonconformance, and quality investigations.Review records to ensure compliance with company procedures and regulatory requirements.Support internal audits and quality system improvements.Collaborate with Engineering, Manufacturing, and Regulatory teams.RequirementsBachelor's degree in Engineering, Life Sciences, or a related field.2–4 years of Quality Assurance experience in a regulated industry.Experience working with DHFs and design control documentation.Knowledge of FDA regulations, ISO 13485, and Good Documentation Practices.Strong attention to detail and organizational skills.Good written and verbal communication skills.Preferred:Medical device industry experience.Exposure to CAPA, change control, and risk management activities.