Quality Engineer 3 - Risk Management

The Quality Engineer Level 3 – Risk Management is an experienced individual contributor within Regulatory and Quality for Diagnostics. This role is responsible for performing and maintaining product and process risk management activities for medical device and/or in-vitro diagnostic products across the full product lifecycle. The position supports new product development, sustaining activities, manufacturing, supplier quality, post-market surveillance, complaints, CAPA, nonconformances, and change management.

The role partners with cross-functional teams, including Quality, Regulatory Affairs, R&D, Manufacturing, Customer Service, Commercial/Sales, Supplier Quality, and Post-Market teams, to ensure risk management activities are completed in accordance with applicable quality system requirements, FDA regulations, ISO 13485, ISO 14971, and other relevant medical device and IVD regulatory expectations.

• Product and process risk management principles for medical devices and IVD products.
• FDA Quality System requirements and applicable regulatory expectations.
• ISO 13485 and ISO 14971 requirements.
• QSR, CDRH, IVDR, MDR, MDSAP, and IEC 62304 regulations and standards.
• Design controls and their relationship to risk management.
• Hazard analysis, use-related risk assessment, fault tree analysis, DFMEA, PFMEA, safety risk analysis, product risk assessments, and benefit-risk evaluations.
• Complaint handling, CAPA, nonconformance, change control, validation, and post-market surveillance processes.
• Root cause analysis and corrective action methods.
• Technical documentation, including requirements, specifications, verification and validation reports, manufacturing procedures, quality records, and risk files.
• Audit and inspection readiness expectations for internal audits, external audits, regulatory inspections, and supplier audits.

The successful candidate should demonstrate the ability to:

• Independently perform assigned risk management activities across product development, manufacturing, sustaining, and post-market lifecycle phases.
• Develop, review, maintain, and evaluate risk management documentation and deliverables.
• Assess whether product, process, software, supplier, manufacturing, service, or labeling changes introduce new hazards or affect existing risk controls.
• Identify, verify, and evaluate the effectiveness of risk controls.
• Interpret technical documentation and identify quality, compliance, or risk implications.
• Produce clear, objective, technically accurate, and inspection-ready documentation.
• Apply analytical thinking, problem-solving, root cause analysis, and risk-based decision-making.
• Support cross-functional teams, design reviews, change review boards, CAPA teams, complaint investigations, and material review activities.
• Provide subject matter input during audits, inspections, and readiness activities.
• Manage multiple priorities and meet project timelines in a dynamic regulated environment.
• Communicate effectively through written, verbal, and interpersonal interactions.

• Works independently on defined assignments while recognizing when escalation is needed.
• Demonstrates strong attention to detail and a commitment to high-quality standards.
• Collaborates effectively with stakeholders across Quality, Regulatory, R&D, Manufacturing, Supplier Quality, Customer Service, Commercial/Sales, and Post-Market teams.
• Maintains objectivity and technical accuracy in risk documentation and assessments.
• Supports a culture of compliance, inspection readiness, and continuous improvement.
• Escalates complex risk questions, safety concerns, or unresolved risk acceptability issues to management or senior technical leaders.
• Contributes constructively to cross-functional decision-making and risk-based discussions.
• Adapts to changing priorities while maintaining focus on quality, compliance, and product safety.

• A minimum of a Bachelor’s degree in engineering, life sciences, biomedical sciences, quality, or a related technical discipline.
• 5+ years of related experience in a regulated medical device, IVD, quality engineering, or product development environment.
• Experience supporting risk management files, hazard analyses, FMEAs, design control documentation, change control, complaints, CAPA, and/or nonconformance processes.
• Experience working on cross-functional teams in regulated product development or sustaining engineering environments.
• Experience evaluating post-market information such as complaints, deviations, nonconformances, service data, and other feedback for potential risk impact.
• Experience supporting internal audits, external audits, regulatory inspections, supplier audits, and inspection readiness activities.
• Practical experience reviewing and maintaining risk files throughout product development, manufacturing, and post-market surveillance phases.