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; prior experience is a plus.
- Working knowledge of Corrective and Preventive Action (CAPA) and Nonconformance (NC) processes.
- Hands-on experience managing quality investigations, including immediate containment, issue bounding, root cause analysis, corrections, and corrective actions.
- Ability to develop clear, objective, and 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 is preferred.
- Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams.
Roles & Responsibilities
- Execute and manage CAPA and Nonconformance investigations in accordance with applicable procedures and quality-system requirements.
- Lead investigation activities from initiation through closure, including 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 the cause of quality issues and support risk-based decisions.
- Coordinate with investigation owners, process owners, subject-matter experts, and other 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; experience with ETQ is 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.
Salary Range: $70,000 - $80,000 a year
TCS Employee Benefits Summary:
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 & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
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