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.
- pply 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.
