Quality Engineer III

Regulatory Jobs; Duryea (Luzerne County); On-site; USD 67,000 - 82,000; Full time

Job summary

Regulatory Jobs is seeking a Quality Systems Leader to provide strategic direction for quality initiatives ensuring product, processes, suppliers, and systems meet regulatory requirements. You will drive CAPA, audits, risk management, and continuous improvement across the organization.

Responsibilities span quality systems, product and process quality, supplier quality leadership, and cross-functional collaboration with R&D to ensure compliance and robust specifications.

Responsibilities

• Serves as 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
• Track and communicate project performance, measurable business impact, cost savings, and quality improvements

Job description

Starting Salary: $74,500

DESCRIPTION/JOB SUMMARY

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

RESPONSIBILITIES/DUTIES

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

Continuous Improvement Leadership

• 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