QA Specialist

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

Benefits offered by this job

Onsite role in California

Job summary

Ultimate Staffing in Carlsbad, CA seeks a Quality Specialist to administer and maintain quality management systems aligned with FDA and ISO 13485 requirements.

The role focuses on documentation, CAPAs, NCRs, supplier certification, calibration programs, and audits across production, testing, and warehousing in a 100% onsite setting.

Qualifications

• 2-5 years of experience in the medical device field.
• Experience with 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.

Responsibilities

• Understand and ensure compliance with the Quality system, recognizing the impact on both the customer and quality.
• Support daily tasks and documentation for the quality system, including NCRs, 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 and initiate non-conforming material documentation and corrective action.
• Perform quality document review and approval of in-process and finished goods documentation before release.
• Support facility calibration and verification programs.
• Assist in developing and maintaining the Supplier Certification program, including on-site audits.
• Serve as an internal and external audit team member and support audits by regulators.
• Assist in administrative functions of the department as necessary.

Skills

Quality management

Documentation

Regulatory compliance

Communication

Bilingual Spanish/English

Education

Bachelor's degree in sciences

Tools

Microsoft Office

Job description

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

Benefits

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

Additional Details

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

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.