Senior Quality Assurance Specialist

Company Overview

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 Senior Quality Assurance Specialist to support and enhance our Quality Management System (QMS) in compliance with FDA 21 CFR Part 820, ISO 13485:2016, ISO 14971:2019; and other applicable requirements for both IVD and RUO products. This role serves as a subject matter expert in quality systems, regulatory compliance, and risk management, 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 strong technical knowledge of molecular diagnostics, a solid understanding of quality management principles, and proven experience applying data-driven decision-making in a regulated environment.

• Develop, implement, and maintain QMS processes compliant with regulatory and industry standards.
• Author, review, and revise quality procedures, work instructions, and forms.
• Manage document control and document changes.
• Maintain a robust training program to ensure all functions are trained and competent to applicable training requirements.
• Monitor QMS performance using KPIs and metrics; identify opportunities for continuous improvement.

• Lead and investigate CAPA and Customer Complaint.
• Apply structured methodologies such as 5-Why, fishbone diagram, fault tree analysis, and 8D for RCA.
• 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 and quality event closures and perform trend analysis to identify systemic issues.
• Maintain complaint files in an audit-ready state and ensure regulatory timelines are met.

• Review and approve manufacturing (MFG) and quality control (QC) process documentation.
• Evaluate and approve RUO product specifications, labeling, packaging, and associated technical 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 risk management activities across the product lifecycle and maintain RM files.
• Participate in risk assessments for product changes, process updates, and CAPA evaluations.
• Ensure implementation and verification of effective risk controls.

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

• 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 scientific field.
• Minimum 3-5 years of Quality Assurance experience in a regulated industry. Experience in the medical device/IVD industry is strongly preferred.
• Hands‑on experience with eQMS compliant with FDA and ISO requirements (Greenlight Guru, IQS, Mastercontrol, Veeva Vault, etc.).
• Strong understanding of molecular diagnostics, including PCR platforms and assay development.
• On-site availability at the Irvine, CA facility (no remote/hybrid option).

• Master’s degree in a related scientific field or Quality Management.
• 5-7 years QA experience in IVD or medical device industries.
• Working knowledge of 21 CFR 820, ISO 13485:2016, and ISO 14971:2019.
• Experience managing eQMS development, implementation, and maintenance.
• Proven track record in complaint handling and CAPA effectiveness.
• Experience with internal/external audits and quality inspection/testing.
• Strong statistical analysis skills (SPC, capability analysis, sampling plans).
• ASQ…