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Quality & Reliability Engineer II

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 

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.

 

This position is responsible for direct interaction and support and customer quality management, assuring that QSRs (Quality Systems Regulation) and QMS (Quality Management Systems) are in accordance with regulatory standards and promote continuous improvement of the Quality System. Other duties may be assigned on an individual basis:  This position will report to the Director/Quality Assurance. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the QMS.

 

ESSENTIAL FUNCTIONS: 
•    Implementation of quality system documentation that is in compliance with the quality manual and associated Standard Operating Procedures (SOPs).
•    Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group.
•    Develop and maintain the pFMEA process for manufacturing.
•    Support/participate in regulatory agency and customer quality audits.
•    Participate in design control activities to ensure that product meet specifications, reliability, and manufacturability.
•    Participate in initiating nonconformance report, Containment, root cause investigation, dispositions and implementation of CAPA.
•    Working knowledge of CAPA management to drive to root cause analysis and practical corrective and preventive solutions. Utilize formal problem-solving techniques to resolve product and/or process related issues.
•    Write and/or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements.
•    Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies.
•    Provide quality engineering support to sending sites during project transfers.
•    Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.
 

What your background should look like:

•    Bachelor’s degree with a scientific / engineering emphasis
•    Minimum of 3-5 years’ related experience
•    Catheter/MI experiences are an advantage 
•    ASQ Certified Quality Engineer or MS in Medical devices engineering, Engineering Management or Mechanical, are an advantage
•    Six Sigma Green / Black belt preferred
 

Competencies

Values: Integrity, Accountability, Teamwork, Innovation
Location: 

PLYMOUTH, MN, US, 55442

City:  PLYMOUTH
State:  MN
Country/Region:  US
Travel:  Less than 10%
Requisition ID:  93731
Alternative Locations: 
Function:  Engineering & Technology


Nearest Major Market: Minneapolis

Job Segment: Facilities, Six Sigma Black Belt, Compliance, Six Sigma, Quality Engineer, Operations, Management, Legal, Engineering

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