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Quality Analyst-Biotechnology/ Medical Device
Job Description
Below are the job details:
Job Title:
Quality Analyst Duration:
18
Months Location:
Pacheco, California 94553 As a Quality Analyst, you will:
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.
Qualifications & Preferred Skills:
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:
$40.00 - $42.84 per hour
Work Location:
In person