Quality Assurance Lead
Bureau Veritas · Knoxville, TN · 1 mo ago
Engineering$75k–$90k/yrFull-time
Major Roles & Responsibilities
- Lead customer audits independently, and support QA Manager for regulatory inspections & agency visits
- Draft audit responses and corrective action plans
- Monitor regulation changes, assess risk, and close compliance gaps
- Affiliate with facilitating scope expansion with regulating/certifying bodies
Strategic Management
- Participate in cross-departmental corrective activities based on trends
- Support quality event trending and corrective actions
- Facilitate cross-departmental communication
- Improve efficiency and effectiveness of quality processes
Reporting & Oversight
- Assist in preparing Management Review Meeting reports
- Report quality systems status to QA Manager
- Develop tracking/trending tools and communicate trends to leadership
- Collaborate with managers on company policies, goals, and procedures
Client Relations
- Resolve client issues to enhance satisfaction
- Lead client audits
- Track deviations, change controls, and complaints
Knowledge, Skills & Abilities
- Leadership: Lead, develop, and motivate QA teams
- Communication: Exceptional written/verbal skills for executive reporting and stakeholder engagement
- Regulatory Expertise: Deep understanding of requirements and proactive compliance management
- Technical Proficiency: Advanced knowledge of QMS, statistical analysis, and validation
- Technical Skills: Expertise in QMS implementation and continuous improvement
- Advanced proficiency with QMS software, databases, and statistical tools
- Expert knowledge of GLP, GMP, and regulatory frameworks
- Management & Leadership: Train and develop QA team on data analysis and quality management
- Interpersonal and relationship-building skills: Strong interpersonal and relationship-building skills
- Project management and coordination skills: Excellent project management and coordination skills
- Analytical & Problem-Solving: Advanced problem-solving for complex quality challenges
- Root cause analysis and corrective action implementation: Expertise in root cause analysis and corrective action implementation
- Attention to detail: Strong attention to detail with strategic perspective
Required Qualifications
- Experience & Educational Background: Bachelor's Degree + 7 years QA experience with progressive responsibility OR Master's Degree + 5 years QA experience with progressive responsibility
- Preferred Laboratory/manufacturing quality management experience
- Regulatory inspection representation experience
- Multiple QMS experience (ISO 17025, ISO 9001, GLP, GMP)