Quality Analyst

Volt; Martinez (CA); On-site; USD 44,000 - 52,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Job summary

Volt is hiring a Quality Analyst in Pacheco, California to support quality systems in Biotech/Medical device environments. The role focuses on nonconformance handling, investigations, and document control to ensure timely resolution and audit readiness.

The ideal candidate holds a science degree, 2–4 years of related QA experience, and knowledge of QA methodologies and regulatory standards such as ISO13485, ISO14971, 21 CFR 820, and IVDR.

Qualifications

• Bachelor's degree in science or related field (or equivalent experience).
• 2-4 years of experience in Biotechnology quality assurance and/or Medical device industry is a plus.
• Intermediate understanding of QA methodologies.
• Experience with ISO13485, ISO14971, 21CFR 820, IVDR and Quality Management regulations.
• Experience with Quality Management System tools (e.g., Electronic Documentation systems).

Responsibilities

• Assist with Nonconformance and customer complaint handling activities with documentation and investigations.
• Support document control activities and KPI reporting.
• Maintain audit-ready records for quality events (CAPAs, deviations, nonconformances, complaints).
• Assist with change control documentation, risk evaluations, and follow-up actions.
• Support internal/external audits and finding closures.

Skills

QA methodologies

Quality assurance

GxP Compliance

Education

Bachelor's degree in science

Tools

Electronic Documentation systems

Job description

Build your future with Volt! Volt is immediately hiring for Quality Analyst in Pacheco, California

• Assist with Nonconformance and customer complaint handling activities by managing documentation, facilitating investigations, and ensuring timely resolution with cross-functional involvement.
• Support effective inter/intra departmental collaboration for overall document control activities supporting IVDR remediation and key performance indicators.
• Maintain accurate, audit-ready records for all quality events including Change control, CAPAs, deviations, nonconformances, and complaints.
• Support document control processes such as document formatting, routing, approval tracking, and archival in alignment with compliance requirements set forth in internal procedures and applicable regulations.
• Support Internal QA ticketing system execution to triage open action items within Quality Department.
• Assist with change control activities, including preparation of documentation, risk evaluations, and follow-up to ensure timely completion.
• Supports internal/external audits to ensure compliance with subject regulations and supports finding closures efficiently.
• Prepares and provides Training for Quality processes related to quality management system as necessary
• Maintains and tracks QMS programs as necessary, including facilitating the progress of deliverables, KPI Reporting, conducting trending analysis and communicating quality compliance issues.

This is a full-time- contract opportunity.

The Ideal Candidate will have:

• Bachelor's degree in science, or related field (or equivalent experience)
• 2-4 years of experience in Biotechnology quality assurance and/or Medical device industry is a plus.
• Intermediate understanding of QA methodologies.
• ISO13485, ISO14971, 21CFR 820, IVDR and Quality Management regulations
• Experience with Quality Management System tools (e.g., Electronic Documentation systems)

Pay Range and Benefits:

Pay Range*: $32 - $37.64 per hour

• health
• dental
• vision
• term life
• short term disability
• AD&D
• 401(k)
• Sick time
• other types of paid leaves (as required by law)
• Employee Assistance Program (EAP)

Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please email [e-mail] or call (866) -898-0005. Please indicate the specifics of the assistance needed.Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

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