QLTY & RELIABILITY ENGINEER II

Job Overview

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:

Main Responsibilities

• Develop and implement world-class processes within the Quality System to support business requirements, working closely with site Quality leaders.
• Serve as a subject matter expert in quality, providing support and guidance in the development of new products and processes.
• Supervise the work of Quality Engineers I and quality technicians, providing mentorship and direction.
• Coordinate and lead quality review meetings with management and key departments.
• Develop and maintain relationships with key suppliers to ensure the quality of received components and materials.
• Perform advanced risk analyses and manage quality risk mitigation across manufacturing processes.
• Design and execute advanced validation and qualification studies for processes and equipment.
• Contribute to the design and improvement of electronic quality systems.
• Ensure validation protocols and reports meet procedural requirements and that obtained evidence aligns with documentation.
• Perform statistical analyses as needed (capability, normality, variance, means, etc.).
• Review production and inspection instructions, visual standards, etc., and align them with the local quality system.
• Follow up on and execute change plans in SmartSolve related to documentation and ERP validation processes.
• Monitor the status of transfer documents and created validations.
• Participate in discussions with representatives from Quality, Engineering, and Production.
• Ensure applicability of current quality policies, procedures, and objectives, staying updated on the latest relevant standards and regulations.
• Plan and execute team projects and activities to facilitate changes in the quality system.
• Create and review quality system documentation.
• Implement and maintain quality management systems in compliance with ISO 13485, FDA QSR, and other applicable medical industry regulations.
• Conduct internal audits and prepare the company for external audits by regulatory bodies and customers.
• Collaborate with product development and manufacturing teams to ensure quality from product conception through market launch.
• Investigate, analyze, and resolve quality issues by implementing effective corrective and preventive actions.
• Manage quality records and documentation, ensuring integrity and regulatory compliance.
• Participate in process and equipment validation, including protocol development, test execution, and report writing

Education

• Bachelor’s degree in science or engineering.
• Degree in Engineering or equivalent discipline

Experienc

• Minimum 2 years of experience in quality roles within the medical industry.
• Demonstrated experience leading quality projects.
• In-depth knowledge of applicable quality standards and regulations (ISO 13485, FDA QSR, etc.).
• Preferred: Professional certifications (CQE, Six Sigma Black Belt).
• Experience on manufacturing process 

Skills and Competencie

• Strong leadership, communication, and negotiation skills.
• High analytical, problem-solving, and project management abilities.
• English level C1 (constant communication with clients and corporate).
• Proficiency in Microsoft Office tools (Word, Excel, Minitab, Project, PowerPoint, Visio).
• Advanced skills in quality management software.
• Ability to manage multiple projects in dynamic environments.
• Strong attention to detail and technical report writing skills

Competencies