Senior Quality Engineer

Role overview

This role is a senior individual contributor on an IVD (in vitro diagnostic) Quality team, supporting the design, rollout, and ongoing care of the quality management system that governs IVD and software-enabled IVD product development. Reporting to the Director of IVD Regulatory and Quality, the engineer acts as the Quality voice on cross-functional product core teams and helps keep design controls, risk management, and design-transfer documentation compliant and audit-ready.

Responsibilities

- Run day-to-day IVD QMS and product-development activities so lifecycle processes stay operational and standards-compliant. - Draft, revise, route, and maintain SOPs, work instructions, forms, templates, and other controlled quality-system documents. - Serve as the Quality representative on assigned product core teams and cross-functional working groups, raising gaps and escalating significant compliance, product-safety, or risk issues. - Support design-control execution, including design plans, inputs and outputs, reviews, traceability, verification and validation documentation, design transfer, and design-history-file records. - Facilitate and review risk-management documentation such as risk plans, assessments, controls, residual-risk records, and traceability to verification and validation activities. - Support change control, nonconformance, deviation, CAPA, complaint handling, and post-market quality processes, including root-cause analysis, action tracking, and effectiveness checks. - Contribute to internal and external audit preparation, objective-evidence gathering, and response coordination. - Compile assigned quality metrics and prepare inputs for governance and management-review forums.

Requirements

- Bachelor's or advanced degree in a scientific, engineering, technical, or related discipline (e.g., biology, chemistry, biomedical engineering, medical technology). - Minimum of 6 years of Quality Engineering or Quality Assurance experience, with at least 4 years in an IVD, molecular diagnostics, or medical device regulated environment. - Practical experience applying FDA Quality System Requirements, ISO 13485, ISO 14971, IEC 62304, and IEC 62366 as applicable. - Strong technical writing skills with a track record of drafting and implementing SOPs, work instructions, and quality templates. - Experience working on cross-functional product development core teams and maintaining audit-ready design-history files.

Nice to have

- Experience with Ketryx or similar connected lifecycle management / automated compliance tools. - Experience supporting regulatory submissions, audits, and inspections. - ASQ Certified Quality Auditor (CQA) or ISO 13485 Lead Auditor certification.

Benefits and work setup

- Fully remote position with a Monday–Friday 9 AM–5 PM EST schedule, coordinated with leadership. - Budgeted pay range disclosed at $131,037–$145,147 USD. - Compensation and benefits aligned with local market practices in each operating country.