Job Description
Job Title: Quality Assurance Specialist (QA Specialist)
Location: Santa Clara, CA
Duration: 6 Months
Industry: Medical Device (Preferred)
Experience: 2–4 Years
Job 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.
Responsibilities
- Maintain 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.
Requirements
- Bachelor'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.