Principal Quality Engineer

Role overview

This is a senior Quality leadership role responsible for shaping, maintaining, and continuously improving the IVD quality management system that supports IVD and software-enabled IVD product development. Reporting to the Director of IVD Regulatory and Quality, the Principal Quality Engineer partners with Regulatory Affairs, R&D, Software Development, Product, Clinical/Medical Affairs, and Cybersecurity to translate regulatory and standards requirements into practical, scalable processes and to advise on significant quality, compliance, product-safety, and risk-based decisions.

Responsibilities

- Lead development and execution of the IVD QMS implementation roadmap, including prioritization, milestones, dependencies, resource needs, and status reporting. - Establish, maintain, and continuously improve the IVD QMS so it supports compliant product development and remediation of systemic gaps. - Translate FDA, ISO, and IEC requirements into practical, scalable procedures, templates, and governance mechanisms. - Act as senior Quality representative in product development, risk management, design review, change control, and lifecycle governance forums, ensuring significant issues are identified, assessed, documented, and escalated. - Provide functional direction, technical oversight, and coaching to Quality personnel; partner with the Director on priorities, workload allocation, and performance feedback. - Review or approve critical QMS procedures, risk decisions, CAPAs, audit and inspection responses, and management-review outputs within delegated authority. - Establish and monitor QMS performance metrics and quality objectives, and lead governance and management-review activities. - Oversee supplier-quality strategy and execution, including risk classification, qualification standards, and escalation of critical supplier issues. - Lead audit and inspection readiness, including preparation, hosting, response development, CAPA follow-up, and monitoring of regulatory and standards changes.

Requirements

- Bachelor's degree in a scientific, engineering, technical, or related discipline; advanced degree preferred. - 10+ years of progressive Quality Assurance or Quality Systems experience in a regulated environment, with at least 6 years in the IVD or medical device industry. - Direct experience implementing or maintaining a QMS for IVDs, molecular diagnostics, or software-enabled medical devices. - Strong working knowledge of FDA Quality System Requirements, ISO 13485, ISO 14971, IEC 62304, and IEC 62366. - Hands-on experience with FDA-regulated product development, design controls, risk management, software lifecycle controls, and post-market quality processes. - Experience supporting FDA inspections, ISO audits, regulatory submissions, and audit-response activities.

Nice to have

- Experience with the Ketryx platform or similar connected lifecycle management / automated compliance tools.

Benefits and work setup

- Fully remote role with a Monday–Friday 9 AM–5 PM EST schedule. - Up to 20% travel, including occasional domestic and international travel for supplier audits and qualification activities. - Budgeted pay range disclosed at $150,458–$168,715 USD. - Compensation and benefits aligned with local market practices in each operating country.