Quality Systems Engineer

Quick Facts

• Salary range: $70,000 - $80,000 a year

Description

This role executes and manages CAPA and Nonconformance investigations according to applicable procedures and quality-system requirements.

Responsibilities

• Lead investigation activities from initiation through closure: containment, issue bounding, data collection, root cause analysis, corrections, corrective actions, and effectiveness planning as applicable.
• Apply structured problem-solving and root cause analysis methods to determine causes of quality issues and support risk-based decisions.
• Coordinate with investigation owners, process owners, subject-matter experts, and cross-functional users to obtain objective evidence and complete assigned actions.
• Facilitate routine investigation follow-up meetings, document decisions and action items, and proactively communicate risks, delays, and escalations.
• Ensure investigation records are accurate, clear, complete, timely, and supported by appropriate evidence and rationale.
• Track CAPA, NC, and investigation milestones; maintain visibility of open actions and support timely closure.
• Enter, update, route, and maintain quality records in the applicable eQMS; ETQ experience preferred.
• Support quality-system metrics, trend reviews, internal audits, and regulatory or customer inspection readiness as assigned.
• Identify opportunities to improve investigation quality, workflow efficiency, and user compliance with established procedures.
• Perform other quality-system duties as assigned.

Requirements

• Strong written and verbal communication skills; ability to clearly document and present investigation outcomes.
• Previous experience in the medical device industry (experience is a plus).
• Working knowledge of CAPA and Nonconformance processes.
• Hands-on experience managing quality investigations, including immediate containment, issue bounding, root cause analysis, corrections, and corrective actions.
• Ability to develop clear, objective, evidence-based investigation documentation that is complete, traceable, and inspection-ready.
• Strong organizational and follow-up skills to coordinate day-to-day activities, action items, timelines, and meetings with system users and cross-functional stakeholders.
• Ability to prioritize multiple investigations and quality-system deliverables while maintaining attention to detail.
• Experience using an electronic Quality Management System (eQMS); ETQ experience preferred.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams.
• Bachelor of Computer Science.

Benefits

• Discretionary annual incentive.
• Comprehensive medical coverage: medical & health, dental & vision, disability planning & insurance, pet insurance plans.
• Family support: maternal & parental leaves.
• Insurance options: auto & home insurance, identity theft protection.
• Convenience & professional growth: commuter benefits, certification & training reimbursement.
• Time off: vacation, time off, sick leave & holidays.
• Legal & financial assistance: legal assistance, 401K plan, performance bonus, college fund, student loan refinancing.