Quality & Reliability Engineer

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.

Responsibilities

• Develop strong links with customer organizations and other project stakeholders
• Overall responsibility for production GMP standards and compliance
• Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues
• Establishing and maintaining FMEA’s
• Preparing and updating Operations procedures and associated documentation
• Supporting internal, customer and surveillance accreditation audits
• Maintain relevant documentation to comply with quality standards and customer requirement
• Support Operations area projects and initiatives
• Quality review of responsible area validation documentation
• Performing an active role in further development and continuous improvement of the quality management system
• Perform an active role in quality planning and new product introduction from a quality perspective
• Establishing inspection standards, plans, frequencies, and test methods other duties as assigned from time to time
• Reporting area metrics
   

What your background should look like:

• Level 8 Quality / Science / Engineering degree
• Experience within a similar role as Quality Engineer
• 5+yrs industry experience in a medical device-manufacturing or pharmaceutical environment
• Working knowledge of FDA/ISO/MDD quality systems for medical device companies. 
• Excellent written and oral communication skills essential. 
• Quality experience in component and device manufacturing desirable. 
• Experience with process validation desirable 

Competencies