QA Specialist

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

QA Specialist (JN -092026-431702) Carlsbad, California

Salary: USD30 - USD32 per hour

Quality Specialist Position Overview

Ultimate Staffing is actively seeking a dedicated Quality Specialist to join their client's team in Carlsbad. This role focuses on administering and maintaining quality management systems in accordance with ISO 13485 and FDA requirements. The Quality Specialist plays a critical role in ensuring compliance and maintaining high-quality standards across all operations.

Responsibilities

• Understand and ensure compliance with the Key quality system, recognizing the impact on both the customer and quality.
• Support daily tasks and documentation associated with the quality system, including Nonconformance reports, Returns, CAPAs, Deviations, and Customer Complaints.
• Conduct Compliance walk-throughs of production, testing, and warehousing areas.
• Revise and maintain documents and records for quality-related functions, update tracking logs and databases.
• Inspect incoming material to blueprints/specification sheets, complete relevant documentation, and initiate non-conforming material documentation, disposition, and corrective action documentation as required.
• Perform quality document review and approval of in-process (work orders) and finished goods (DHRs) before release, documenting all work on appropriate records.
• Support facility equipment calibration and verification program.
• Assist in developing and maintaining the Supplier Certification program, including on-site product audits and follow-up on discrepancies and corrections.
• Serve as an internal and external audit team member, responsible for planning and conducting audits as assigned, and supporting audits by external regulatory authorities.
• Assist in administrative functions of the department as necessary.
• Perform other functions as assigned by management based on department needs.

Qualifications

• 2-5 years of experience in the medical device field (or related industry).
• Bachelor's degree in sciences is a plus.
• Experience in Quality Systems for the medical device industry.
• Familiarity with Medical Device regulations (FDA and ISO 13485).
• Basic working knowledge of Microsoft Office, specifically Word, Excel, Outlook.
• Excellent written and verbal skills.
• Spanish-English bilingual is a plus.

Required Work Hours

Monday - Friday

The position offers a competitive pay range with a maximum pay of $32 per hour and a minimum pay of $30 per hour.

The role is 100% onsite in California and involves active participation in various quality assurance processes to ensure the highest standards are maintained.