Quality Engineer

Job Title:

Quality Engineer

Job Description

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.

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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…