Job Summary We are seeking an experienced Quality Engineer to support risk management, design controls, and product lifecycle activities for Class II and/or Class III medical devices. The candidate will be responsible for developing, reviewing, and maintaining risk management documentation in accordance with ISO 14971, supporting DFMEA and PFMEA activities, and ensuring compliance with medical device quality and regulatory requirements. This role will also support remediation initiatives, Design History File (DHF) updates, and audit readiness activities in collaboration with cross-functional teams.
Roles and Responsibilities
Develop, review, and maintain product risk management documentation in accordance with ISO 14971.
Participate in Design Failure Mode and Effects Analysis (DFMEA) and Process Failure Mode and Effects Analysis (PFMEA) activities.
Update and maintain risk management files, hazard analyses, and risk assessment documentation.
Perform risk assessments related to design modifications, process changes, and product lifecycle activities.
Maintain traceability between product requirements, identified risks, risk control measures, and verification and validation activities.
Support Design Control activities and review design documentation for completeness and compliance.
Review, update, and maintain Design History File (DHF) documentation.
Support remediation activities related to risk management, design controls, and quality system compliance.
Collaborate with Engineering, Quality Assurance, Regulatory Affairs, and Manufacturing teams to address product risks and documentation gaps.
Assist with internal and external audit preparation by ensuring risk management and design control records are complete, accurate, and readily available.
Prepare and maintain technical documentation in accordance with applicable medical device quality standards and regulatory requirements.
Support continuous improvement initiatives related to risk management processes and product quality.
Education & Experience
Bachelor's degree in engineering or a related technical discipline.
5 10 years of experience in the medical device industry, preferably in Quality Engineering, Risk Management, or Design Assurance.
Hands-on experience with ISO 14971 medical device risk management processes.
Working knowledge of DFMEA, PFMEA, hazard analysis, and risk assessment methodologies.
Experience supporting design controls and maintaining Design History File (DHF) documentation.
Experience with Class II and/or Class III medical devices.
Experience supporting remediation activities, design changes, and product lifecycle documentation.
Numbers & Facts
Location
Danvers, MA
Skills
Continuous Improvementunmatched
Cross-Functionalunmatched
Design Failure Mode and Effects Analysis (DFMEA)unmatched
Documentationunmatched
External Auditunmatched
File Maintenanceunmatched
Hazard Analysisunmatched
Healthcare Qualityunmatched
ISO (International Organization for Standardization)unmatched
Insurance Regulationsunmatched
Internal Auditunmatched
Maintain Complianceunmatched
Manufacturing Requirementsunmatched
Medical Equipmentunmatched
Process Failure Mode and Effects Analysis (PFMEA)unmatched
Product Designunmatched
Product Documentationunmatched
Product Lifecycleunmatched
Product Requirements Document (PRD)unmatched
Product Reviewsunmatched
Quality Assuranceunmatched
Quality Engineeringunmatched
Quality Metricsunmatched
Regulatory Requirementsunmatched
Risk Analysisunmatched
Risk Managementunmatched
Technical Writingunmatched
Traceabilityunmatched
Validation Testingunmatched
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