Quality Engineer III

Starting Salary: $74,500

Provides technical leadership and strategic direction for quality engineering initiatives that ensure product, product enhancements, processes, suppliers, and quality systems meet company, customer, and regulatory requirements

• Serves as a subject matter expert in quality systems, supplier quality, auditing, regulatory compliance, continuous improvement, and new product development
• Lead development, implementation, maintenance, and continuous improvement of Quality Management System Regulations (QMSR) processes in accordance with FDA Quality Management System Regulations, ISO 13485
• Serve as a subject matter expert for quality system processes including CAPA, nonconformance containment, complaint handling, auditing, document control, and risk management
• Lead complex investigations involving recurring, systemic, high-risk, or customer-impacting quality issues
• Review and approve CAPA investigations, root cause analyses, corrective actions, and effectiveness verification activities
• Evaluate quality system performance metrics and recommend strategic improvements.
• Support organizational audit readiness and regulatory compliance initiatives
• Assist management in developing departmental quality objectives and performance metrics

• Lead resolution of complex product, process, and supplier quality issues utilizing advanced problem-solving methodologies
• Analyze quality trends, manufacturing metrics, field performance data, warranty information, and customer feedback to identify systemic improvement opportunities
• Drive corrective and preventive actions that improve product quality, process capability, and customer satisfaction
• Establish quality metrics and monitoring systems that support business objectives
• Participate in cross-functional collaboration with Research and Development (R&D) to ensure regulatory compliance and specification development is executed
• Provide technical leadership in statistical analysis, process capability studies, and quality improvement initiatives
• Review and approve quality-related investigations and recommendations
• Develop and present high-level reports regarding problematic quality issues to outline mitigation activities

• Lead supplier quality management activities for critical suppliers and strategic supplier development initiatives
• Conduct supplier audits and assessments to evaluate supplier compliance, capability, and performance
• Lead supplier corrective action activities and verify implementation and effectiveness of corrective actions
• Partner with Purchasing, Engineering, and Operations to improve supplier performance and mitigate supply chain risks
• Support supplier qualification and approval activities for new suppliers and new product introductions
• Work with management to develop supplier quality performance metrics and improvement plans

• Lead cross-functional continuous improvement initiatives utilizing Lean, Six Sigma, DMAIC, and other quality methodologies
• Facilitate teams focused on reducing defects, improving efficiency, lowering costs, improving customer satisfaction, and enhancing quality performance
• Identify and prioritize opportunities for quality, operational, and business process improvements

• Serve as a senior quality representative on new product development and product launch teams
• Lead quality planning activities for new product introductions, including risk management, First Article Inspection Review (FAIR) Board, validation, and design transfer activities
• Review and approve Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs)
• Provide…