Senior Quality Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the development, implementation, and upkeep of product-development Quality Management System (QMS) processes for GeneDx’s In Vitro Diagnostic (IVD) and software-enabled IVD products.

• Carry out designated IVD QMS and product-development tasks while ensuring compliance with lifecycle processes.

• Create, revise, route, approve, and maintain Standard Operating Procedures (SOPs), work instructions, forms, templates, and other controlled QMS documentation.

• Act as the Quality representative on designated product core teams and cross-functional working groups.

• Offer Quality review and guidance, pinpoint quality-system deficiencies, and escalate critical Quality, compliance, product-safety, and risk-related issues.

• Aid in design-control processes, encompassing design plans, inputs and outputs, reviews, traceability, verification and validation, design transfer, and design-history-file records.

• Facilitate and evaluate risk-management plans, assessments, controls, residual-risk documentation, and traceability.

• Assist with change control, nonconformance, deviation, CAPA, complaint management, and post-market quality processes.

• Provide support for internal and external audits and inspection readiness, including evidence preparation, tracking corrective actions, and responding to observations.

• Gather and analyze Quality metrics for governance and management review.

• Identify process deficiencies, compliance risks, and potential improvement areas, implementing risk-based solutions.

• Support supplier-quality activities, including managing supplier documentation, assessing design-transfer readiness, conducting change evaluations, and following up on corrective actions.

• Foster a culture of quality, accountability, continuous improvement, and collaboration across functions.

⛳️ Requirements

• A bachelor’s or advanced degree in a scientific, engineering, technical, or related field (e.g., Biology, Chemistry, Biomedical Engineering, Medical Technology).

• A minimum of 6 years of experience in Quality Engineering or Quality Assurance.

• At least 4 years of experience specifically within an IVD, molecular diagnostics, or medical device regulated environment.

• Hands-on experience with FDA quality-system requirements, ISO 13485, ISO 14971, IEC 62304, and IEC 62366, as applicable.

• Proficiency in technical writing and QMS development.

• Experience in drafting, revising, and implementing SOPs, work instructions, and quality templates.

• Strong comprehension of the product development lifecycle.

• Experience working on cross-functional core teams.

• Experience in supporting regulatory submissions and audits/inspections.

• Capability to manage multiple projects and priorities in a fast-paced environment.

• Familiarity with Ketryx or similar connected lifecycle management and automated compliance tools is a plus.

• Preferred certifications include ASQ CQA, ASQ CQE, ISO 13485 Internal Auditor, and/or ISO 13485 Lead Auditor.

🏝️ Benefits

• Competitive compensation.

• Benefits that align with local market practices and legal requirements in each country where GeneDx operates.

• Fully remote work option from a home office or other appropriate remote location.

• Work schedule from Monday to Friday, 9 AM to 5 PM EST.

• Provision of standard office equipment, including a computer, phone, and video conferencing tools.