Job Summary

The Lead Quality Engineer is responsible for ensuring that products meet both internal and external quality and reliability standards throughout the product lifecycle. This role has direct reports and involves leading quality planning, process validation, risk assessment, and problem-solving initiatives to support product development, manufacturing, and customer satisfaction.

Job Responsibilities

• Interface with Customer, Operations, Engineering, Inspection, and supply chain teams to ensure product quality and compliance
• Lead/support root cause analysis and corrective/preventive actions (CAPA) for product issues
• Ensure compliance with industry standards and regulatory requirements (e.g., ISO 9001, AS9100, ISO 13485, FDA, etc.)
• Manage quality metrics and reporting, including yield, defect rates, and customer returns
• Conduct or support internal, supplier, and customer audits
• Develop/update and maintain documentation including inspection plans and qualification reports
• Support continuous improvement initiatives such as Six Sigma or Lean Manufacturing
• Perform MRB reviews and document nonconformance concession submittals to customer, respond to customer inquiries
• Provide technical expertise and guidance to company employees, suppliers, customers and regulatory agencies to ensure compliance with contractual, company, and regulatory requirements
• Able to perform in an Engineer/Training coordinator role to ensure that activities between production, manufacturing and Quality are clearly defined, communicated and understood
• Provide education and coaching on the company's quality system
• Responsible for obtaining MRB approval for preparing dispositions for product nonconformance to meet all requirements
• Process customer returned product
• Facilitate MRB meetings and track actions & progress; internally and with customers

Job Qualifications

• Have a fundamental understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems and professional ethics
• Understand elements of a Quality Management System and its development, documentation and implementation to applicable domestic and international standards and/or requirements
• Understand the audit process and its role within a Quality Management System; including types of audits, reporting results and follow-up
• Develop and implement quality plans, including tracking, analyzing, reporting and problem solving
• Demonstrate ability to lead problem-solving and quality improvement events and utilize tools and techniques. This includes knowledge of management and planning tools, quality tools, preventive and corrective actions, and how to overcome barriers to quality improvements
• Possess strong written, communication and interpersonal skills
• Possess a pro-active mindset with a passion for utilizing Continuous Improvement techniques to improve processes
• Computer literate in Excel, Word, Access, and PowerPoint
• Must be able to work in a production manufacturing environment and travel throughout the facilities and corporation to obtain information needed to perform job functions
• Specific Vision abilities required; including close vision, distance vision, color vision, peripheral vision, depth perception and ability to focus with a specific requirement for corrected vision at 20/25 or better