QA Specialist

Techtrueup • Santa Clara, CA

14h • Onsite

About The Position

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.

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.

Nice To Haves

• Medical device industry experience.
• Exposure to CAPA, change control, and risk management activities.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level