Quality Assurance Specialist

Seegene USA, Inc. is a leading molecular diagnostics company dedicated to advancing healthcare through innovative in vitro diagnostic (IVD) solutions. Our portfolio includes molecular diagnostics leveraging advanced PCR technology. We are committed to delivering high-quality diagnostic tools that improve patient outcomes while upholding the highest standards of regulatory compliance and quality excellence.

Seegene USA is seeking a highly motivated and detail-oriented Quality Assurance Specialist to support and enhance our Quality Management System (QMS) in compliance with FDA 21 CFR Part 820 and ISO 13485:2016, and other applicable requirements for both IVD and RUO products. This role serves as a subject matter expert in Manufacturing and post-market quality area, working cross-functionally with R&D, Manufacturing/Operations, Regulatory Affairs, and Customer Service to ensure product quality and drive continuous improvement.

The ideal candidate brings a solid understanding of quality management principles, and proven experience applying data-driven decision-making in a regulated environment.

• Review and approve manufacturing (MFG) and quality control (QC) process documentation.
• Review and approve batch production records, ensuring completeness and accuracy.
• Manage, investigate, and document deviations occurring during manufacturing or QC.
• Maintain audit-ready documentation and ensure compliance with applicable U.S. quality expectations for diagnostic products.

• Support supplier qualification, evaluation, and auditing activities.
• Maintain supplier quality metrics and collaborate with Procurement and Operations on quality issues.
• Investigate supplier quality issues (SCARs), review corrective actions, monitor effectiveness, and track supplier performance trends.

• Lead and investigate CAPA.
• Conduct complaint investigations and determine MDR-reportability under 21 CFR Part 803.
• Investigate nonconformances for root causes of defects, process deviations, and appropriate dispositions.
• Ensure timely closure of CAPA, complaints and Nonconformance and perform trend analysis to identify systemic issues.
• Maintain complaint files in an audit-ready state and ensure regulatory timelines are met.

• Manage document control and document changes.
• Maintain a robust training program to ensure all functions are trained and competent to applicable training requirements.
• Author, review, and revise quality procedures, work instructions, and forms as needed.

• Support internal audits including planning, execution, and reporting.
• Prepare audit responses and track corrective actions through closure in the eQMS.

• Analyze quality data to identify trends and opportunities for improvement.
• Apply Statistical Process Controls and other statistical tools to monitor process capability and product quality.
• Update quality dashboards, reports, and management review presentations, as required.

• Bachelor’s degree in molecular biology, Biochemistry, Microbiology, Biotechnology, Biomedical Engineering, Chemistry, or related life science field.
• Minimum 2+ years of Quality Assurance experience in a medical device/IVD industry.
• Hands-on experience with eQMS such as Agile, Greenlight Guru, IQS, Master Control, Veeva Vault, etc.
• Experience managing eQMS implementation, and maintenance.
• Proven track record in complaint handling and CAPA effectiveness.
• On-site availability at the Irvine, CA facility no remote/hybrid option.

• Master’s degree in a related scientific field or Quality Management.
• Knowledge of PCR assay, understanding of molecular diagnostics assay is a plus.
• Working knowledge of FDA QMS, ISO 13485:2016, and ISO 14971:2019.
• Experience with internal/external audits and quality inspection/testing
• Strong statistical analysis skills (SPC, capability analysis, sampling plans)
• ASQ certifications (CQA, CQE, CSQP), Six Sigma Green/Black Belt, and ISO auditor certifications preferred.

• Ability to work on-site during standard business hours with occasional extended hours.
• Ability to sit for prolonged periods and use a computer.
• Occasional standing, walking, bending, and lifting up to 25 lbs.
• Visual acuity to read documentation and inspect materials.
• Occasional travel (