Quality Engineer

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

📋 Description

• Assist in the implementation, upkeep, and ongoing enhancement of established IVD supplier quality and post-market quality processes.

• Collaborate with Procurement and relevant stakeholders on supplier onboarding, risk assessment, qualification, change management, monitoring, and performance oversight.

• Maintain accurate records of supplier qualifications, Quality Agreements, and the Approved Supplier List.

• Conduct or assist in supplier audits and evaluations; prepare audit documentation and ensure the closure of supplier corrective actions.

• Assess supplier-initiated changes and quality incidents for their impact on product quality, supply continuity, or regulatory compliance; escalate intricate or high-risk evaluations.

• Facilitate supplier readiness during design transfer by verifying qualification status, documentation, and process controls.

• Carry out post-market quality tasks, including complaint intake and investigation support, nonconformances, deviations, CAPAs, quality-event documentation, action tracking, and effectiveness checks.

• Investigate quality events related to suppliers and evaluate their contributions to complaints, deviations, nonconformances, or other post-market occurrences.

• Compile metrics on supplier and post-market quality; assist in trend analysis, management reviews, and quality governance initiatives.

• Draft and update supplier quality and post-market quality procedures, work instructions, forms, templates, and quality records compliant with established QMS standards.

• Aid in audit and inspection readiness by organizing objective evidence and addressing requests under Quality leadership.

• Identify gaps in processes and opportunities for improvement, escalating recommendations for broader QMS modifications.

⛳️ Requirements

• Bachelor’s degree in a scientific, engineering, technical, or related field.

• A minimum of 3 years of experience in Quality Engineering, Quality Assurance, supplier quality, or related roles, with at least 2 years in an IVD, molecular diagnostics, medical device, or similarly regulated environment.

• Familiarity with supplier qualification, monitoring, quality agreements, corrective actions, change assessments, and performance management.

• Experience in at least one post-market quality process, such as complaint handling, nonconformance management, deviation management, CAPA, investigations, or quality trending.

• Solid understanding of applicable FDA quality system requirements, ISO 13485, and ISO 14971.

• Experience conducting or assisting in supplier audits and assessments.

• Knowledge of product development, design transfer, and supplier readiness activities.

• Ability to implement defined quality processes, manage multiple priorities, and escalate issues as necessary.

• Preferred certifications include ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 13485 Internal Auditor, and/or ISO 13485 Lead Auditor.

• Consistent high-speed internet access.

🏝️ Benefits

• Competitive salary and benefits packages that reflect local market practices and legal requirements in each country where GeneDx operates.