QA Specialist

Job Title: Quality Assurance Specialist (QA Specialist)
Location: Santa Clara CA
Duration: 6 Months
Industry: Medical Device (Preferred)
Experience: 24 Years

Job Summary
We are looking for a Quality Assurance Specialist with 24 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

• Bachelors degree in Engineering Life Sciences or a related field.
• 24 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.

Additional Information :

All your information will be kept confidential according to EEO guidelines.

Remote Work :

No

Employment Type :

Contract