Quality Engineer III

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

Quality Systems Leadership

• 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

Product and Process Quality

• 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

Supplier Quality Leadership

• 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
• Track and communicate project performance, measurable business impact, cost savings, and quality improvements
• Promote a culture of continuous improvement throughout the organization

New Product Development and Validation

• 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 quality oversight for process validation activities, including DQ/IQ/OQ/PQ protocols and reports
• Ensure quality and regulatory requirements are effectively incorporated into product development activities
• Support design verification, validation, and risk management activities

Auditing and Regulatory Compliance

• Lead internal quality system audits, supplier audits, process audits, and finished device/ component audits
• Serve as a primary quality personnel during customer audits, third-party audits, and regulatory inspections
• Identify compliance risks and lead corrective actions to closure
• Interpret regulatory and quality standard requirements and provide…