About this role

Job title: Quality Analyst

Highlights

As a Quality Analyst, you will:

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
Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Volt offers benefits (based on eligibility) that include the following: health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
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.

Quality Analyst