Quality Systems Engineer

We are seeking a 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 documentation.

The candidate should be highly organized, detail-oriented, and capable of managing multiple investigations and quality-system deliverables while collaborating effectively with cross-functional stakeholders.

• Strong written and verbal communication skills with the ability to clearly document and present investigation outcomes.
• Previous experience in the medical device industry.
• Working knowledge of CAPA and Nonconformance (NC) processes.
• Hands-on experience managing quality investigations, including:
• Containment
• Issue bounding
• Root-cause analysis
• Corrections
• Corrective actions
• Ability to develop clear, objective, evidence-based investigation documentation.
• Strong organizational and follow-up skills.
• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
• Execute and manage CAPA and Nonconformance investigations in accordance with applicable procedures and quality-system requirements.
• Lead investigations from initiation through closure, including:
• Immediate containment
• Issue/problem definition and bounding
• Data collection
• Root-cause analysis
• Corrections
• Corrective actions
• Effectiveness planning, where applicable
• Apply structured problem-solving and root-cause analysis methodologies to determine the causes of quality issues.
• Support risk-based decision-making and ensure appropriate documentation of investigation conclusions.
• Coordinate with investigation owners, process owners, subject-matter experts, and cross-functional stakeholders to obtain objective evidence and complete assigned actions.
• Facilitate investigation follow-up meetings and document decisions, action items, risks, and escalations.
• Proactively communicate investigation status, delays, risks, and potential escalation requirements.
• Ensure investigation records are accurate, clear, complete, timely, traceable, and supported by appropriate evidence and rationale.
• Track CAPA, NC, and investigation milestones and maintain visibility of open actions through timely closure.
• Enter, update, route, and maintain quality records in the applicable electronic Quality Management System (eQMS).
• Support quality-system activities and ensure documentation is inspection-ready.
• Maintain strong follow-up and coordination across multiple quality-system activities.
• Ensure compliance with applicable company procedures and regulatory requirements.