Bachelor's degree in Engineering, Life Sciences, or related field
5+ years of hands-on experience in quality systems within regulated environments
Strong understanding of CAPA and Nonconformance processes
Proficient in conducting root-cause analysis and corrective actions
Demonstrated ability to produce clear, evidence-based documentation
Responsibilities
Execute and manage CAPA and Nonconformance investigations
Lead investigations from initiation through closure
Apply structured problem-solving methodologies for quality issues
Coordinate with cross-functional teams for objective evidence collection
Communicate investigation status proactively and clearly
Ensure accuracy and completeness of investigation records
Support quality-system compliance and maintain inspection readiness
Benefits
Collaboration with cross-functional teams
Exposure to regulatory compliance challenges
Opportunity for professional development in a critical industry
Engagement in impactful quality assurance initiatives
Full Job Description
Job Description:
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.
Responsibilities:
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.
pply 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.
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
Must-Have Technical / Functional Skills:
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.
