About nRichDX

nRichDX is a medical device company based in Irvine, California, focused on advancing liquid biopsy and precision medicine through innovative sample preparation technologies. Our patented Revolution Sample Prep System™ enables high-yield, high-recovery isolation of cfDNA, cfRNA, and CTCs from blood, plasma, urine, and other biofluids across a wide range of sample volumes.

By maximizing analyte recovery and improving downstream assay sensitivity, nRichDX helps researchers and clinicians achieve more accurate and confident molecular test results for early detection, disease monitoring, and precision medicine applications.

Job DescriptionKey Responsibilities

• Lead corporate initiatives to establish and maintain quality assurance and regulatory programs both across and within departments/functions to ensure that responsibilities and procedures for attaining QMS objectives are consistently met.
• Lead QMS management meetings to review and report on the effectiveness of the QMS.
• Manages the company's internal audit program, as required, to determine QMS effectiveness and to assure compliance with the established regulatory requirements.
• Act at the company's Quality Management Representative.
• Effectively implement corrective and preventive actions, and corrections, as necessary to address nonconformities and prevent their recurrence.
• Fulfill medical device reporting requirements (where appropriate) for FDA.

Minimum Qualifications

• Degree required: College: Bachelor of Science in engineering or related life science field.
• Must have experience as a quality engineer/manager in IVD/medical diagnostics.
• Current 'hands-on' experience with the following: CAPA, NCR, DCR, Complain, statistical analysis, establishment and maintenance of Quality Systems, design control, document control, procedure writing, risk management, design review, auditing, verification, validation, process control and improvement.
• Working understanding of applicable regulatory and industry standards including, but not limited to, ISO 13485, ISO 14971, 21CFR820, IVDD.
• Legal resident of the United States of America.

Desired Skills and Experience

• Molecular diagnostics experience preferred.
• FDA 510k device submission/approval process a plus.
• At least 3 years of experience in quality and/or regulatory experience in IVD.