Collaborate with cross-functional stakeholders to collect evidence and resolve issues.
Facilitate follow-up meetings and document related decisions and action items.
Monitor investigation status and communicate milestones and risks.
Ensure accuracy and completeness of all records in the electronic Quality Management System.
Benefits
Engagement in high-impact projects that improve patient safety.
Collaborative work environment across multiple disciplines.
Continual learning and professional development opportunities.
Exposure to a regulated medical-device landscape enhancing career growth.
Opportunity to find and implement process improvement initiatives.
Full Job Description
Job Summary: We are seeking a highly organized and detail-oriented Quality Systems Engineer to support quality system activities within a regulated medical-device environment. The ideal candidate will have hands-on experience with CAPA, Nonconformance (NC) investigations, root-cause analysis,corrective actions, and quality-system documentation.
Roles & Responsibilities:
Manage and execute CAPA and Nonconformance (NC) investigation s in accordance with established procedures, quality-system requirements, and applicable medical-device regulations.
Apply structured problem-solving and root-cause analysis methodologies to identify and address the underlying causes of quality issues.
Conduct risk-based assessments and ensure investigation conclusions are supported by objective evidence, sound rationale, and appropriate documentation.
Partner with investigation owners, process owners, subject-matter experts, and cross-functional stakeholders to collect evidence, resolve issues, and complete assigned actions.
Facilitate investigation follow-up meetings and document decisions, action items, risks, dependencies, and escalations.
Monitor and communicate investigation status, milestones, overdue actions, risks, and potential escalation requirements.
Ensure CAPA, NC, and investigation records are accurate, complete, clear, timely, traceable, and inspection-ready.
Track investigation milestones, action items, commitments, and due dates to support timely closure.
Enter, update, review, route, and maintain quality records within the applicable electronic Quality Management System (eQMS).
Support quality-system activities, documentation reviews, audits, and inspection-readiness initiatives.
Maintain effective follow-up and coordination across multiple investigations and quality-system deliverables.
Ensure activities are performed in compliance with company procedures, quality policies, and applicable regulatory requirements.
Identify recurring quality issues, trends, and opportunities for process improvement and communicate findings to relevant stakeholders.
Collaborate effectively with Quality, Manufacturing, Engineering, Operations, Regulatory, and other cross-functional teams.
Education & Experience:
Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.
Preferred: Degree in Biomedical, Mechanical, Electrical, Chemical, Industrial Engineering, or a related field.
3+ years of experience in Quality Engineering, Quality Systems, Quality Assurance, or a related role within the medical-device industry.
Hands-on experience managing CAPA and Nonconformance (NC) investigations in a regulated environment.
Demonstrated experience leading investigations through the complete lifecycle, including containment, issue definition/bounding, data collection, root-cause analysis, corrections, corrective actions, and closure.
