Medical Device Quality Assurance Specialist

Ultimate Staffing Services; Carlsbad (CA); On-site; USD 39,000 - 41,000; Full time

Job summary

Ultimate Staffing Services is seeking a Medical Device Quality Assurance Specialist in Carlsbad, CA. The role focuses on maintaining and improving the quality system, handling nonconformances, CAPAs, and supplier audits.

The position involves documentation, records review, material inspection, calibration support, and participation in internal and external audits to ensure regulatory compliance and product quality.

Responsibilities

• Ensure compliance with the Key quality system and its impact on customer and quality.
• Document and support quality system tasks: Nonconformance reports, Returns, CAPAs, Deviations, and Customer Complaints.
• Conduct compliance walkthroughs of production, testing, and warehousing areas.
• Revise and maintain quality documents and records; update tracking logs and databases.
• Inspect incoming material to specifications; document and disposition non-conforming material.
• Review and approve in-process and finished goods records before release; document actions.
• Support calibration and verification of facility equipment.
• Contribute to Supplier Certification program; perform on-site audits and follow-ups on discrepancies.
• Participate in internal and external audits; assist regulatory authority audits.
• Assist in department admin and other duties as needed.

Skills

Quality Assurance

Regulatory Compliance

Auditing

Job description

Medical Device Quality Assurance Specialist (JN -092026-431699) Carlsbad, California

Salary: USD28 - USD30.25 per hour

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.