KH
Quality Systems Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Manager or above
2 weeks ago
- CAPA
2 weeks ago
Not enough detail in this posting to match
- 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.
- 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.
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
- 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.
Quality Systems Engineer · Katalyst Healthcares & Life Sciences