Quality Engineer

Role overview

This role is a hands-on Quality Engineer focused on supplier quality and post-market quality processes for IVD and software-enabled IVD products. Reporting to the Director of IVD Regulatory and Quality, the engineer partners with senior Quality team members and cross-functional stakeholders to qualify and monitor suppliers, run supplier audits, and execute complaint handling, nonconformance, deviation, CAPA, and quality-trending activities.

Responsibilities

- Support implementation, maintenance, and continuous improvement of supplier-quality and post-market quality processes. - Partner with Procurement and other stakeholders on supplier onboarding, risk classification, qualification, change management, monitoring, and performance management; maintain Quality Agreements and the Approved Supplier List. - Conduct or support supplier audits and assessments, prepare audit reports, and track supplier corrective actions to closure. - Evaluate supplier-initiated changes and quality events for impact on product quality, supply continuity, or regulatory status, escalating complex or high-risk assessments. - Confirm supplier qualification status, documentation, and process controls during design transfer. - Execute post-market quality activities such as complaint intake, investigation support, nonconformances, deviations, CAPAs, action tracking, and effectiveness checks. - Investigate supplier-related quality events and assess whether supplier materials, reagents, software, services, or performance contributed to post-market events. - Compile supplier and post-market metrics and support trend reporting, management review, and quality governance. - Draft and maintain supplier-quality and post-market procedures, work instructions, forms, templates, and quality records. - Support audit and inspection readiness by organizing objective evidence and responding to requests under Quality leadership direction.

Requirements

- Bachelor's degree in a scientific, engineering, technical, or related discipline. - Minimum of 3 years of Quality Engineering, Quality Assurance, supplier quality, or related experience, including at least 2 years in an IVD, molecular diagnostics, medical device, or similarly regulated environment. - Experience with supplier qualification, monitoring, quality agreements, supplier corrective actions, change assessments, and performance monitoring. - Experience supporting at least one post-market quality process such as complaint handling, nonconformance, deviation, CAPA, investigations, or quality trending. - Working knowledge of FDA Quality System Requirements, ISO 13485, and ISO 14971. - Experience conducting or supporting supplier audits and assessments, plus familiarity with design transfer and supplier readiness.

Nice to have

- ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 13485 Internal Auditor, and/or ISO 13485 Lead Auditor certification.

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 $84,871–$93,166 USD. - Compensation and benefits aligned with local market practices in each operating country.