Work Flexibility: Onsite
As a Quality Engineer, you will support Quality Assurance activities within a regulated medical device environment, partnering with Manufacturing, Research & Development, Regulatory, and Engineering teams. You will monitor product and process quality, investigate nonconformances, manage quality data, and support compliance with FDA Quality System requirements, ISO 13485, and the Medical Device Single Audit Program (MDSAP).
What you will do
Investigate product and process quality issues with cross-functional teams, performing risk assessments, historical record reviews, nonconformance evaluations, and corrective action activities.
Coordinate containment and disposition of nonconforming product, including identification, segregation, reconciliation, and documented resolution.
Monitor and trend quality data to identify potential issues and provide data-based quality insights to management.
Manage Corrective and Preventive Action (CAPA) activities and verify compliance with Quality Management System requirements.
Apply statistical methods to establish sampling plans and evaluate the effectiveness of corrective actions.
Interpret risk management documentation, including Failure Modes and Effects Analysis (FMEA), to support quality and risk-based decisions.
Support internal and external audits, respond to audit findings, and evaluate Quality Management System changes required to maintain regulatory compliance.
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Partner with Quality Assurance, Manufacturing, Engineering, Research & Development, and Regulatory teams to resolve quality issues and escalate risks requiring management review.
What you will need
Required
Bachelor’s degree in Engineering or a related technical field.
Minimum 5 years of Quality Engineering experience.
Professional proficiency in English and Spanish, written and verbal.
Working knowledge of FDA 21 CFR Part 820, ISO 13485, and MDSAP.
Experience using Microsoft Word and Excel.
Preferred
Experience working in the medical device industry or another regulated manufacturing environment.
Experience with CAPA, nonconformance management, FMEA, risk management, statistical sampling, and quality audits.
Travel Percentage: 20%
