Principal Quality Engineer

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

📋 Description

• Spearhead the development and execution of the IVD Quality Management System (QMS) implementation roadmap, encompassing process prioritization, milestones, cross-functional dependencies, resource requirements, and status updates.

• Establish, maintain, and perpetually enhance the IVD quality management system.

• Address and rectify identified systemic gaps within the quality system.

• Convert regulatory and standards requirements into actionable, scalable quality processes, procedures, templates, and governance frameworks.

• Act as the senior Quality representative in product development, risk management, design reviews, change control, and lifecycle governance forums.

• Identify, evaluate, document, and escalate critical quality, compliance, product safety, and risk-related issues.

• Provide functional guidance, technical oversight, and mentoring to Quality personnel.

• Collaborate with the Director of IVD Regulatory and Quality on priorities, workload distribution, and performance evaluations.

• Review or ensure the review and approval of essential quality system procedures, significant quality risk decisions, CAPAs, audit and inspection responses, and management review outputs.

• Establish and monitor performance metrics and quality objectives for the QMS.

• Lead quality governance and management review activities, including tracking actions and assessing negative trends or systemic process deficiencies.

• Oversee the supplier quality strategy and its execution, which includes supplier risk classification, qualification standards, and escalation of critical supplier quality risks.

• Direct audit and inspection readiness activities, including preparation, hosting, response development, CAPA follow-up, and regulatory oversight.

• Cultivate and maintain a culture of quality, accountability, and continuous improvement across cross-functional teams.

⛳️ Requirements

• A Bachelor’s degree in a scientific, engineering, technical, or related field is required; an advanced degree is preferred.

• Over 10 years of progressive experience in quality assurance or quality systems within a regulated environment.

• At least 6 years of experience specifically in the IVD or medical device industry.

• Direct experience in implementing or maintaining a quality management system for IVDs, molecular diagnostics, and/or software-enabled medical devices.

• Strong working knowledge of relevant FDA quality system requirements and ISO 13485, ISO 14971, IEC 62304, and IEC 62366.

• Experience with FDA-regulated product development, design controls, risk management, software lifecycle controls, and post-market quality processes.

• Experience in supporting FDA inspections, ISO audits, regulatory submissions, and audit response efforts.

• Strong judgment and the ability to apply a risk-based, practical approach to quality and compliance.

• Excellent written and verbal communication skills, including the ability to explain quality requirements to both technical and non-technical stakeholders.

• Capability to lead multiple complex initiatives in a fast-paced, cross-functional setting.

• Willingness to travel up to 20% of the time, including occasional domestic and international travel.

• ASQ CQA and/or ISO 13485 Lead Auditor certification is strongly preferred.

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

🏝️ Benefits

• Competitive compensation and benefits that are aligned with local market practices and legal requirements in each country where GeneDx operates.

• Fully remote work from a home office or another suitable remote location.

• Standard work hours from Monday to Friday, 9 AM to 5 PM EST.

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