Quality Assurance Analyst (Medical Device & Biotechnology)

VOLT • Pacheco, CA

15h • Onsite

About The Position

Volt is immediately hiring for a Quality Assurance Analyst (Medical Device & Biotechnology) in Pacheco, CA. This role involves supporting various quality management system processes, including nonconformance investigations, customer complaints, corrective actions, document control, and regulatory compliance initiatives. The analyst will also assist with audits, training, and quality metrics analysis.

Requirements

• Bachelor's degree in Science, Biology, Biotechnology, Engineering, or a related field, or equivalent experience.
• 2-4 years of experience in Quality Assurance within the Medical Device, Biotechnology, Life Sciences, or regulated manufacturing industry.
• Working knowledge of Quality Management Systems (QMS).
• Experience with ISO 13485
• Experience with ISO 14971
• Experience with FDA 21 CFR Part 820
• Experience with IVDR regulations
• Experience with CAPA and Change Control processes
• Experience with Electronic document management systems
• Strong organizational, analytical, and documentation skills.
• Ability to work effectively in cross-functional teams and manage multiple priorities.

Responsibilities

• Support nonconformance investigations, customer complaints, and corrective action activities.
• Maintain audit-ready documentation for CAPAs, deviations, change controls, complaints, and nonconformances.
• Support Quality Management System (QMS) processes and KPI reporting.
• Manage document control activities, including formatting, routing, approvals, tracking, and archival.
• Assist with IVDR remediation projects and regulatory compliance initiatives.
• Support internal QA ticket management and follow-up on quality action items.
• Participate in change control activities, risk assessments, and documentation reviews.
• Assist with internal and external audits and support timely closure of audit findings.
• Deliver training on quality system processes and compliance requirements.
• Analyze quality metrics and trends, identify risks, and communicate compliance issues to stakeholders.

Benefits

• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level