TE Connectivity’s Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication.
What your background should look like:A Quality & System Engineer uses their engineering skills to assist in issues related to the Quality of the product. This job also involves leveraging advanced technical skills to resolve issues related to the product to meet quality goals.
RESPONSABILITIES AND TASKS
Apply problem-solving techniques Working align requirements in the medical industry (FDA regulations), ISO 13485. Apply statistical tools, quality, and reliability software to resolve problems. Apply spreadsheets, databases, and Process Control Monitoring (SPC). Leadership in process improvement, Six Sigma. Responsible to CAPA/NCR Process in San Rafael site including CAPA Review Board meetings, risk assessment for CAPA events. Measure and monitoring the effectiveness of the implemented quality systems Ensure the quality system’s suitability, adequacy, and effectiveness through Quality Management Reviews. Assure appropriate executions of non conformities events and corrective & preventive actions. Review, examine, approve and recommend changes to local procedures and other related documents to assure compliance with Global, regulatory and ISO 13485 & FDA requirements Responsible to implement improvement solutions for CAPA and Management Review processes and provide technical guidance. Responsible for policies and practices to comply with applicable government regulations and industry requirements Perform root cause analysis; determine corrective action and verify effectiveness. Ensure corrective and preventive action plans are developed and implemented. Assist in the coordination of quality system continuous improvement processes. Create and modify current procedures and instructions. Conduct training for personnel to ensure compliance with company procedures. Prepare and present technical and program information for team members and management. Perform internal audits within the company to ensure compliance with applicable standards / regulatory requirements and organizations and ISO. Communicate issues or events discovered during major quality assurance audits and recommend process improvements to the quality system manager. Prepare reports to communicate quality metrics. Maintain a working knowledge of government and industry quality assurance standards
Job Specific Knowledge, Skills and Abilities
Knowledge - NCMRs/CARs/CAPA, Customer Complaints per million, Abilities- Abilities are an underlying, enduring trait useful for performing tasks (oral comprehension, understanding information and ideas). Language: Bilingual English (Intermediate)/ Spanish. Knowledge of problem-solving techniques. Knowledge of working requirements in the medical industry (FDA regulations). Knowledge of statistical tools, quality and reliability software. Detailed knowledge of FDA, GMP and ISO 13485. Knowledge of measuring instruments, sampling plans.
EXPERIENCE & EDUCATIONAL REQUIREMENTS
Experience
1-2 year of experience in a Quality System Quality leadership experience working in a manufacturing environment, ideally in a multi-national environment.
Education
Bachelor’s Degree with a scientific or engineering emphasis. Professional Training & Certifications - Six Sigma Green Belt Internal/Lead auditor ISO13485