Quality Analyst

VOLT•Pacheco, CA

8d•Onsite

About The Position

Volt is immediately hiring for Quality Analyst in Pacheco, California. 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. You will support effective inter/intra departmental collaboration for overall document control activities supporting IVDR remediation and key performance indicators. You will maintain accurate, audit-ready records for all quality events including Change control, CAPAs, deviations, nonconformances, and complaints. You will 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. You will support the Internal QA ticketing system execution to triage open action items within the Quality Department. You will assist with change control activities, including preparation of documentation, risk evaluations, and follow-up to ensure timely completion. You will support internal/external audits to ensure compliance with subject regulations and support finding closures efficiently. You will prepare and provide training for Quality processes related to the quality management system as necessary. You will maintain and track QMS programs as necessary, including facilitating the progress of deliverables, KPI Reporting, conducting trending analysis and communicating quality compliance issues.

Requirements

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)

Responsibilities

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.