QLTY & RELIABILITY ENGINEER I

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:

Nature and Overall Purpose of the Role Performed

•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, product and process qualification, new product transfer and validation.
•Investigate complaints from customers, suppliers, and internal non-conformities.
•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.
•Develop and analyze statistical data and specifications to determine standards and establish product quality expectations.
•Validate new equipment or processes. (IQ / OQ / PQ)
•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 manager.
•Prepare reports to communicate quality metrics.
•Maintain a working knowledge of government and industry quality assurance standards.
•Function as a resource for Quality System related issues.
•Ensure a high level of internal and external customer service.
•Make improvements that minimize the cost of quality, specifically rejects, failures and any production defects.
•Work with production in solving production and quality related problems.
•Follow all duties as assigned by the Quality Manager.
•Must be able to support departments such as Doc Control, Training, Calibrations, Incoming, Environmental Monitoring, Pest Control and Methods.

COMPETENCIES & SKILLS 
 
Core Competencies 

•Technical Learning - Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.
•Problem Solving- Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn’t stop at the first answers.
•Action Oriented - Enjoys working hard; is action oriented and full of energy for the things that he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.

 

Job Specific Knowledge, Skills and Abilities 
•Knowledge - NCMRs/CARs/CAPA, Customer Complaints per million, Quantity of returned product (RMAs), DPPM, DLPM.  

Skills/ Abilities

•Language: Bilingual English (Intermediate)/ Spanish. 
•Knowledge of Microsoft Office.
•Knowledge of problem-solving techniques.
•Knowledge of working requirements in the medical industry (FDA regulations).
•Excellent knowledge of Creganna Quality System.
•Knowledge of statistical tools, quality and reliability software.
•Knowledge of spreadsheets, databases, and Process Control Monitoring (SPC). 
•Experience in process improvement, Six Sigma, product and process qualification and validation.
•Detailed knowledge of FDA, GMP and ISO 13485.
•Experience in new product transfer.
 

Competencies