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US-Quality Engineer II

Equiliem
United States, California, Camarillo
Jan 25, 2025
Job Title: Quality Engineer II What are the top 3-5 critical skills or must have skills a candidate should have on their resume in order to be considered? * Develop, implement, and monitor molding and stamping processes to ensure optimal performance and product quality. * Lead root cause analysis and corrective actions for molding and stamping-related defects. * Collaborate with cross-functional teams (production, quality, and design) to resolve technical issues and improve processes. * Perform quality inspections and validations for molded and stamped parts to ensure compliance with specifications. * Conduct process capability studies (e.g., Cp, CpK) and implement process controls for molding and stamping. * Drive continuous improvement initiatives to optimize manufacturing efficiency and reduce scrap rates. * Ensure compliance with industry standards, quality requirements, and regulatory guidelines. What You ll Do: As a Quality Engineer II, you will be responsible for ensuring product quality, reliability, and compliance with regulatory requirements throughout the product lifecycle. Leveraging your experience and technical expertise, you will support quality assurance activities, drive process improvements, and contribute to the development and implementation of quality management systems. Functions: Support the development and implementation of quality management systems (QMS), including policies, procedures, standards, and documentation, to ensure compliance with regulatory requirements and industry standards. Participate in product development and design control activities, including risk management, design verification/validation, and change control, to ensure product quality and regulatory compliance. Conduct root cause analysis, failure investigations, and CAPA (Corrective and Preventive Action) activities to address quality issues, non-conformances, and customer complaints. Perform quality engineering activities, including statistical analysis, process capability studies, and design of experiments (DOE), to optimize processes and improve product quality and reliability. Collaborate with cross-functional teams, including R&D, manufacturing, supply chain, and customer service, to resolve quality issues, implement corrective actions, and support continuous improvement initiatives. Lead and participate in internal and external audits, inspections, and regulatory assessments to ensure compliance with quality standards, regulations, and customer requirements. Provide technical support and guidance to manufacturing operations, suppliers, and other stakeholders to ensure adherence to quality standards and specifications. Required Qualifications: Bachelor s degree in Engineering, Science, or related field. 3-6 years of experience in quality engineering, quality assurance, or a related role, preferably in a regulated industry such as medical devices, pharmaceuticals, or aerospace. Strong knowledge of quality management principles, methodologies, and tools, including statistical process control (SPC), root cause analysis, and risk management. Experience with quality management systems (QMS) and regulatory requirements, such as ISO 13485, FDA QSR, and EU MDR. Proficiency in statistical analysis software (e.g., Minitab) and quality engineering tools and techniques. Excellent problem-solving and analytical skills, with the ability to analyze complex issues, identify root causes, and implement effective solutions. Effective communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders. Preferred Skills: Master s degree in Quality Engineering, Industrial Engineering, or related field. Professional certification in quality engineering or related areas (e.g., ASQ Certified Quality Engineer, Six Sigma Green Belt). Experience with risk management methodologies (e.g., FMEA, Hazard Analysis). Familiarity with validation and verification processes and protocols. Knowledge of Lean Six Sigma methodologies and tools for process improvement. Previous experience with quality management software/systems (e.g., TrackWise, MasterControl).