QA Associate

Quality Assurance Associate | $30.25/hour DOELocation: Carlsbad, CAJob type: Contract to hireStart date: Urgent need; candidates available to start as soon as October 5, 2026, are encouraged to apply.We’re seeking a Quality Assurance Associate for a medical device manufacturer in Carlsbad. In this role, you’ll support the quality management system, review production records, inspect incoming materials, and help ensure compliance with FDA requirements and ISO 13485. We’re looking for someone who can work independently, communicate clearly across departments, and keep accurate records. What You’ll Do

• Maintain quality system records and support processes involving nonconformances, returns, CAPAs, deviations, and customer complaints.
• Conduct compliance walk-throughs in production, testing, and warehouse areas.
• Review and maintain quality documents, tracking logs, and databases.
• Inspect incoming materials against blueprints and specifications; document results and initiate nonconforming material records when needed.
• Review in-process work orders and finished goods Device History Records (DHRs) before release.
• Support equipment calibration and verification activities.
• Assist with supplier certification, product audits, discrepancy follow-up, and supplier investigations.
• Participate in internal audits and support external regulatory audits.
• Work with Engineering, Manufacturing, Servicing, Customer Service, and Quality/Regulatory teams.

Qualifications

• 2–5 years of experience in medical devices or a related regulated industry.
• Experience working with medical device quality systems and familiarity with FDA requirements and ISO 13485.
• Ability to review technical documents, identify discrepancies, and maintain accurate records.
• Strong written and verbal communication, critical thinking, and time management skills.
• Working knowledge of Microsoft Word, Excel, and Outlook.

Preferred: A bachelor’s degree in a science field and Spanish-English bilingual skills.If you have medical device quality experience and are available to start soon, apply today!#MS-CBMFG