Quality Assurance Specialist

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.Position Summary: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. Key Responsibilities include:Manufacturing 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. Supplier Quality ManagementSupport 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.CAPA, Customer Complaints, Nonconformances 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. Additional Responsibilities may include:Quality Management System 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.Audit SupportSupport internal audits including planning, execution, and reporting.Prepare audit responses and track corrective actions through closure in the eQMS.Data Analysis and Statistical Methods 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. Required Education and Experience: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). Preferred Education and Experience: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. Physical Requirements & Work Environment: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 (<10%) for audits, training, or conferences.Job Type: Full Time – Salaried ExemptPay:Up to $110,000 D.O.E. Work Location: In Person (at our facility next to UCI) Benefits:401(k)Dental insuranceHealth insurancePaid time offVision insuranceSeegene USA is an equal opportunity employer and values diversity in the workplace. We do not discriminate on the basis of race, color, ethnicity, national origin or ancestry, sex, gender, gender identity, sexual orientation, religion or creed, age, marital or family status, pregnancy or disability, veteran status or military service, genetic information, or any other status protected by applicable federal, state, or local laws.