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 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.

Key Responsibilities

Quality Management System

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.

Quality Events (CAPA, Customer Complaints, Nonconformances)

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.

Product Quality Oversight

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.

Risk Management

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.

Supplier Management

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.

Audit Support

Support 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 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).

Preferred Education and Experience

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 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.

What We Offer

Competitive salary commensurate with experience.
Comprehensive benefit package including medical, dental, and vision insurance.
401(k) with company match.
Paid time off and holidays.
Collaborative environment with exposure to cutting-edge diagnostic technology.
Strong opportunities for career growth within a rapidly expanding company.
Chance to make a meaningful impact on global infectious disease diagnostics.

Seegene 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.

To apply please email:
hr.seegeneusa@seegene.com