Quality Engineer 4 - Risk Management

Hologic•San Diego, CA

About The Position

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.

Requirements

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, and 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.
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 to mentor less experienced engineers and cross-functional team members on risk management practices and tools.
Significant experience in quality engineering, risk management, or related roles within the medical device and/or IVD industry.
Experience leading risk management activities across new product development, sustaining engineering, manufacturing, supplier-related changes, post-market surveillance, complaints, CAPA, and change management.
Experience serving as a technical risk management representative on complex cross-functional project teams, design reviews, change review boards, CAPA teams, complaint investigations, and material review activities.
Experience developing, maintaining, reviewing, and improving risk management files and related deliverables.
Experience conducting and facilitating complex FMEAs, hazard analyses, fault tree analyses, safety risk analyses, and product risk assessments.
Experience evaluating product, process, supplier, software, manufacturing, service, or labeling changes for impact to hazards, risk controls, residual risk, and benefit-risk conclusions.
Experience supporting internal audits, external audits, regulatory inspections, supplier audits, and notified body assessments.
Experience mentoring Quality Engineers and cross-functional partners on risk management principles, FMEA practices, hazard analysis, risk control effectiveness, and risk-based decision-making.

Responsibilities

Lead complex product, process, and quality system risk assessments.
Develop, review, maintain, and remediate risk management files and related quality engineering deliverables.
Facilitate technical risk discussions with clinical, product, engineering, manufacturing, quality, regulatory, and post-market subject matter experts.
Assess post-market data such as complaints, nonconformances, deviations, service records, adverse event trends, customer feedback, and quality signals.
Identify gaps, inconsistencies, and improvement opportunities in risk documentation, design files, manufacturing documentation, CAPA records, complaint investigations, and change assessments.
Support audits, regulatory inspections, supplier audits, notified body assessments, and inspection readiness activities.
Ensure risk conclusions are objective, justified, complete, consistent, and aligned with regulatory requirements.
Mentor less experienced engineers and cross-functional team members on risk management practices and tools.
Operate with a high degree of independence and accountability.
Demonstrate sound technical judgment in complex and ambiguous situations.
Proactively identify risk management gaps, compliance concerns, and improvement opportunities.
Escalate significant safety, compliance, residual risk, or unresolved risk acceptability concerns to appropriate leadership or governance forums.
Collaborate effectively across functions and sites to integrate risk management into the quality management system.
Drive risk-based decision-making and continuous improvement.
Maintain a strong focus on patient safety, product quality, compliance, and inspection readiness.
Communicate clearly and objectively with technical and non-technical stakeholders.
Provide leadership without direct authority by influencing teams and guiding risk management practices.
Support a culture of quality, compliance, transparency, and continuous improvement.