Quality Engineer

Quality Engineer

The Quality Engineer leads and supports all aspects of quality assurance within a contract manufacturing environment, with a strong focus on corrective and preventive actions, data-driven process improvement, and adherence to industry standards. This role drives zero-defect initiatives, supports new product introduction, and collaborates closely with cross-functional teams to ensure products consistently meet customer and regulatory requirements across diverse markets such as medical, military, semiconductor, and electronics.

Responsibilities:

• Lead and manage Corrective and Preventive Actions (CAPA) to resolve quality issues, including identifying root causes, implementing corrective actions, and verifying the effectiveness of these actions.
• Use the 8D problem-solving process to evaluate and document non-conforming products and processes, ensuring thorough root cause analysis and structured follow-up.
• Collect, analyze, and interpret quality data to identify trends, root causes of defects, and opportunities for improvement using statistical methods and tools.
• Develop and maintain software-based or automated reporting systems to monitor production quality and communicate performance metrics, where applicable.
• Participate in New Product Introduction activities and First Time Build reviews, contributing to the development and implementation of robust Quality Control Plans.
• Develop and implement zero-defect quality control strategies in the production process, working closely with production teams to ensure adherence to quality standards and continuous improvement.
• Design or support the creation of Poka-Yoke solutions and inspection fixtures to prevent defects and improve inspection effectiveness.
• Plan, conduct, and document internal and supplier quality audits to ensure compliance with customer requirements, specifications, and relevant standards such as AS9100 and other quality management systems.
• Prepare audit reports, communicate findings, and track the implementation and closure of corrective actions arising from audits.
• Maintain and update quality documentation, including control plans, inspection criteria, work instructions, and standard operating procedures, ensuring alignment with regulatory and company standards.
• Provide training and guidance to production and support staff on quality control procedures, inspection techniques, and best practices.
• Promote and support a culture of quality awareness and continuous improvement throughout the organization.
• Facilitate and sustain compliance with regulatory and certification body requirements related to safety, quality, and security.
• Apply Lean and Lean Six Sigma principles to drive continuous improvement initiatives in operations and business processes.
• Collaborate cross-functionally with engineering, production, supply chain, and other departments to ensure quality standards are understood, implemented, and maintained.
• Support process improvement initiatives by using scorecards, data analysis, and statistical process control (SPC) to monitor and enhance performance.

Essential

Skills:

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, or Integration Engineering.
• Ideally 3 to 5 years of experience in a quality engineering role within a manufacturing environment.
• Strong knowledge and hands-on experience with CAPA processes and methodologies.
• Experience using the 8D methodology for root cause analysis and corrective action.
• Demonstrated ability to perform root cause analysis in manufacturing settings.
• Proficiency in data analysis tools and software for monitoring and improving product quality.
• Experience with quality management systems and standards such as AS9100, ISO 9001:2015, and ISO 13485.
• Familiarity with IPC standards, including IPC-A-610 and IPC-A-620.
• Experience conducting internal and supplier quality audits.
• Knowledge of statistical process control (SPC) and other statistical methods for quality monitoring.
• Experience in manufacturing and contract manufacturing environments.
• Ability to apply Lean and process improvement techniques to enhance operations.
• Strong communication and collaboration skills to work effectively with cross-functional teams.

Additional Skills &

Qualifications:

• Certification in Quality Engineering (CQE) is a plus.
• Six Sigma certification or formal Six Sigma training is a plus.
• Experience applying Lean Principles and Lean Six Sigma methodologies to drive continuous improvement is highly desirable.
• Experience developing or using scorecards to track and report quality performance.
• Background in electronics manufacturing or exposure to electronics-focused environments is beneficial.
• Experience in industries such as medical, military, semiconductor, or other regulated markets is an advantage.
• Interest from engineering students or early-career professionals from technical schools who are eager to grow in electronics and quality engineering is welcomed.

Work Environment:

This role is based within a contract manufacturing environment that…