Design Quality Engineer

Job Summary The Staff Quality Engineer is responsible for ensuring IVD products meet regulatory and quality requirements throughout the product lifecycle. This role leads quality engineering activities, supports product development and manufacturing, and drives continuous improvement within the Quality Management System (QMS). Key Responsibilities Develop and maintain quality systems and processes in compliance with FDA 21 CFR Part 820, ISO 13485, IVDR 2017/746, and ISO 14971. Perform risk assessments and hazard analyses for IVD products throughout the product lifecycle. Lead internal and external audits, including preparation, execution, and follow-up. Manage CAPA, nonconformance, deviation investigations, and complaint handling. Collaborate with cross-functional teams to integrate quality requirements into product design, verification, and validation activities. Review and approve design control documents, including design inputs/outputs, V&V protocols, and risk management files. Establish and maintain Design History Files (DHF). Qualify and assess suppliers during development and production. Analyze quality metrics and trends to identify opportunities for improvement. Support regulatory submissions and product approvals. Manage post-market activities, including MDRs, EU incident reporting, field actions, and failure trending. Update procedures, policies, and training materials to align with changing regulations and best practices. Required Qualifications Bachelor’s degree in Engineering, Life Sciences, or related field. 8+ years of experience in medical device design and development. Strong expertise in Design Controls, Risk Management, and Quality Systems. Experience in FDA-regulated environments. Working knowledge of IVD products and applicable regulations. Preferred Qualifications Experience with FDA 21 CFR Parts 803, 806, and 820; ISO 13485; ISO 14971; IVDR; CAP; and CLIA. ASQ Certification and/or Regulatory Affairs Certification (RAC). Key Skills Quality Management Systems (QMS) Design Controls and DHF Management Risk Management (ISO 14971) CAPA and Nonconformance Investigations Auditing and Supplier Quality Regulatory Compliance Data Analysis and Continuous Improvement Project Management and Cross-Functional Collaboration Work Arrangement Hybrid role requiring 3–4 days onsite in Marlborough, Massachusetts. Potential for conversion from contract to permanent based on business needs.