Quality Assurance Engineer

Key Responsibilities

• CAPA Management: Lead and manage Corrective and Preventive Actions (CAPA) to resolve quality issues. Use the 8D process for evaluating and documenting non-conforming product and processes. This includes identifying root causes, implementing corrective actions, and verifying the effectiveness of these actions.
• Data Analysis: Collect, analyze, and interpret quality data to identify trends, root causes of defects, and areas for improvement. Use statistical methods to monitor and improve product quality. Proficiency in creating software systems to report on production quality is a plus.
• New Product Introduction: Participate in New Product Introduction and First Time Build review and development of Quality Control Plan.
• Zero Defects Quality Control: Develop and implement strategies aimed at achieving zero defects in the production process. Work closely with production teams to ensure adherence to quality standards and continuous improvement. Experience creating Poka-Yoke solutions and inspection fixtures.
• Quality Audits: Conduct internal and supplier audits to ensure compliance to customer requirements and specifications. Develop audit reports and track the implementation of corrective actions.
• Documentation: Maintain and update quality documentation, including control plans, inspection criteria, and standard operating procedures (SOPs). Ensure all documentation meets regulatory and company standards.
• Training: Provide training and support to production staff on quality control procedures and best practices. Foster a culture of quality awareness and continuous improvement within the organization.
• Compliance: Facilitate and sustain of regulatory and certification body in safety, quality, and security.
• Lean: Use of Lean Six Sigma principles to promote continuous improvement initiatives in operations and business aspects or operations.
• Collaboration: Work cross-functionally with other departments, to ensure quality standards are adhered to.

• Bachelor's degree in Electrical, Mechanical, or Integration Engineer.
• Ideally, 3 to 5 years of experience in a quality engineering role within a manufacturing environment.
• Strong knowledge of CAPA processes and methodologies.
• Proficiency in data analysis tools and software.
• Experience with quality management systems (QMS) and standards (AS9100, ISO
  9001:2015, ISO
  13485).
• Knowledge of IPC-A-610, IPC-A-620, and JSTD-001.
• Certification in Quality Engineering (CQE) or Six Sigma is a plus.
• Experience in Lean Principles is a plus.
• Some experience in contract manufacturing.