Senior Quality Engineer

Role Overview

• Serves as a lead core team member of cross functional project teams
• Supervises the Quality Assurance Engineering team
• Reviews quality Key Performance Indicator (KPI) data
• Reviews validations and risk management activities
• Leads and conducts problem solving through change management
• Reviews and edits nonconformance investigation and disposition phases for team members
• Other duties as assigned

Requirements

• Bachelor’s degree in relevant technical discipline
• 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience.
• Combination of advanced degree and experience may be considered.
• AATB or CTBS Certification, preferred
• Lead Auditor Certification, preferred
• ASQ – CQE, CBA, or CQA, preferred
• Excellent verbal and written communication
• Technical writing
• Problem solving methodologies
• Microsoft Office Suite
• Quality Management System software
• Investigations
• Statistical techniques

Benefits

• N/A