Quality Manager

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Come join Cancer Treatment Optimization | QCDx - QUANTITATIVE CELL DIAGNOSTIX | Farmington

QCDx Overview

Precision cancer medicine depends on early cancer diagnosis, personalized treatments and monitoring of treatment efficacy and surveillance for disease recurrence. QCDx is developing a breakthrough platform for detecting and profiling rare cells in blood, including Circulating Tumor Cells (CTC). We obtain real-time intelligence from cells-of-interest by analyzing multiple cancer-related markers while maintaining cell viability for single-cell isolation and downstream molecular analyses. QCDx's 'enrichment-free' CTC detection and profiling technology, RareScope, and our isolation of cells that represent the living tumor's characteristics, provide highly sensitive CTC detection across the stages of disease and enable deeper characterization of each patient's cancer.

Job Summary

We are seeking a motivated and experienced Quality Manager to join our team, contributing to the readiness of our RareScope Technology platform's introduction to the clinical and commercial diagnostic market. The Quality Manager will be responsible for developing, implementing, and maintaining a Quality Management System (QMS) for our clinical laboratory and for the design and manufacturing of our devices. This is a newly created position and brings with it the opportunity to collaborate with the team on building a robust and right-sized QMS to support growth of the business. The Quality Manager will be the subject matter expert and will provide leadership in the implementation of ISO, GMP and GCP standards. The Quality Manger will also be responsible for the company's safety program, including laboratory safety and regulatory compliance. This role will involve ongoing interaction with internal team members across departments, vendors, and partners, influencing these internal and external stakeholders to successfully embed a robust quality assurance culture.

Responsibilities

• Lead the establishment, maintenance and improvement of the QMS to ensure compliance with 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304 and QMS requirements under CLIA.
• Support the Company's regulatory strategy and country-specific IVD requirements (e.g., CE marking under IVDR, FDA 510(k) support).
• Manage documentation processes and support the team in complying with documentation requirements under the QMS.
• Establish and maintain supplier qualification and monitoring programs, conduct supplier audits, manage supplier corrective actions, and collaborate with procurement to ensure material quality and traceability.
• Provide QMS employee training.
• Maintain the Device History Record (DHR).
• Assist with product and process risk management.
• Track non-conformance and its consequences and work with the team to implement Corrective and Preventive Action (CAPA), Root Cause Analysis (RCA), Failure Mode and Effect Analysis (FEMA), and any resulting Performance Improvement Plans (PIP).
• Support post-market surveillance activities.
• Oversee the equipment calibration program.
• Laboratory Safety: in conjunction with the CLIA Lab Director and Engineering Manager, evaluate and audit the laboratory safety program as it pertains to procedures, policies, and training. (Included but not limited to biosafety, chemical safety, fire safety, infection control, laser safety).

Qualifications

• Demonstrable communication, documentation, and organizational skills to seamlessly communicate and guide a highly skilled team of specialists in product development and clinical operations
• Bachelor's degree in a relevant scientific/engineering discipline.
• Minimum 5 years of quality experience in the IVD, medical device, or life sciences industry.
• Minimum 2–3 years in a quality leadership or management role.
• Strong knowledge of ISO 13485, ISO 14971, IEC 62304, IVDR, and FDA 21 CFR 820.
• Experience with validation (IQ/OQ/PQ), CAPA systems, risk management, and audits.
• Hands-on experience with QMS software is a plus.
• Proficiency with measurement tools (calipers, micrometers, CMMs, vision systems, etc.).
• Proven track record managing quality audits, health authority inspections, and inspection readiness.
• Effective interpersonal and communication skills with the ability to work in a fast-paced, collaborative environment.
• Organized and detail-oriented, with excellent planning capabilities.

Additional Information

QCDx is an innovative biotechnology company providing customers with superior research and development expertise since its inception in 2017. Our long-term success is a direct result of a strong commitment to the success of our employees.

QCDx is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, or because he, she, them is an individual with a disability, protected veteran or other status protected by federal, and state laws.