Quality Engineer 4 - Risk Management

Job Summary The Quality Engineer Level 4 – Risk Management is a highly experienced individual contributor responsible for leading complex product, process, and quality system risk management activities within assigned product, processes or projects in support of medical device and/or in-vitro diagnostic products. This role applies advanced technical judgment to develop, maintain, and improve risk management documentation and practices across the product lifecycle, including but no limited to new product development, sustaining, manufacturing, supplier-related activities, post-market surveillance, complaints, CAPA, and change management **The Quality Engineer Level 4 – Risk Management** is a senior, highly experienced individual contributor responsible for leading complex risk management activities across the medical device and/or in-vitro diagnostic product lifecycle. The role provides technical leadership for product, process, software, supplier, manufacturing, service, labeling, and quality system risk management activities. This position supports new product development, sustaining engineering, manufacturing, post-market surveillance, complaints, CAPA, change management, audits, and regulatory inspection readiness. The role works independently, applies advanced technical judgment, mentors others, and partners cross-functionally with Quality, Regulatory Affairs, R&D, Manufacturing, Customer Service, Commercial/Sales, Supplier Quality, and Post-Market teams to ensure risk management practices are technically justified, documented, inspection-ready, and aligned with applicable regulatory requirements. **Knowledge** - Strong knowledge of medical device and/or IVD risk management principles across the full product lifecycle. - Advanced understanding of applicable regulatory and quality system requirements, including: - FDA Quality System requirements - ISO 13485 - ISO 14971 - EU IVDR - MDSAP - Other applicable medical device and IVD standards and regulations - Knowledge of design controls, change control, validation, CAPA, complaint handling, post-market surveillance, nonconformance management, and quality system processes. - Understanding of risk management file structure, content, maintenance, remediation, and inspection readiness expectations. - Knowledge of risk analysis tools and methods, including: - FMEA - Hazard analysis - Fault tree analysis - Safety risk analysis - Benefit-risk evaluation - Understanding of how product, process, supplier, software, manufacturing, service, and labeling changes may affect hazards, risk controls, residual risk, and overall risk acceptability. - Familiarity with audit and inspection expectations for risk management documentation and quality engineering deliverables. **Skills** - Ability to lead complex product, process, and quality system risk assessments. - Strong technical judgment and ability to make risk-based decisions. - Ability to develop, review, maintain, and remediate risk management files and related quality engineering deliverables. - Strong cross-functional facilitation skills, including leading technical risk discussions with clinical, product, engineering, manufacturing, quality, regulatory, and post-market subject matter experts. - Ability to assess post-market data such as complaints, nonconformances, deviations, service records, adverse event trends, customer feedback, and quality signals. - Skilled in identifying gaps, inconsistencies, and improvement opportunities in risk documentation, design files, manufacturing documentation, CAPA records, complaint investigations, and change assessments. - Strong problem-solving skills, including root cause analysis and risk-based prioritization. - Ability to support audits, regulatory inspections, supplier audits, notified body assessments, and inspection readiness activities. - Strong documentation skills to ensure risk conclusions are objective, justified, complete, consistent, and aligned with regulatory requirements. - Ability…