Medical Device QA Specialist - ISO 13485 | Onsite CA

Ultimate Staffing Services; Carlsbad (CA); On-site; USD 41,000 - 44,000; Full time

Job summary

Ultimate Staffing Services in Carlsbad, CA is seeking a Quality Specialist to administer and maintain quality systems per ISO 13485 and FDA requirements. The role emphasizes compliance, documentation, CAPAs, deviations, and supplier audits to uphold high-quality standards across operations.

The position is 100% onsite in California, with responsibilities including document review, calibration program support, audits, and cross-functional collaboration to resolve quality issues.

Qualifications

• 2–5 years in the medical device field or related industry.
• Experience with quality systems for medical devices (FDA and ISO 13485).
• Bachelor's degree in sciences is a plus.
• Proficient with MS Office (Word, Excel, Outlook).

Responsibilities

• Understand and ensure compliance with the quality system and its impact on customers and quality.
• Support daily tasks and documentation for quality system, including nonconformance reports, CAPAs, deviations, and customer complaints.
• Conduct compliance walk-throughs of production, testing and warehousing areas.

Skills

Quality systems

Medical device QA

Documentation

Audit support

MS Office

Education

Bachelor's degree in sciences

Tools

Microsoft Word

Microsoft Excel

Outlook

Job description

Ultimate Staffing Services in Carlsbad, CA is seeking a Quality Specialist to administer and maintain quality systems per ISO 13485 and FDA requirements. The role emphasizes compliance, documentation, CAPAs, deviations, and supplier audits to uphold high-quality standards across operations.

The position is 100% onsite in California, with responsibilities including document review, calibration program support, audits, and cross-functional collaboration to resolve quality issues.