Quality Engineer

TE Connectivity Ltd Campbell, CA
Company Information

TE Connectivity Ltd., is a $13 billion global technology and manufacturing leader creating a safer, sustainable, productive, and connected future. For more than 75 years, our connectivity and sensor solutions, proven in the harshest environments, have enabled advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With 78,000 employees, including more than 7,000 engineers, working alongside customers in nearly 150 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.

TE's Medical business unit, part of the Industrial Solutions segment, offers medical device OEMs, a complete product offering, and capability portfolio for minimally invasive, imaging, surgical, diagnostic, and therapeutic devices. With more than 350 design engineers and a global presence in all key medical device hubs, we are a premier partner to the world's leading medical technology companies for their next-generation medical devices. We are experts in all aspects of device design and manufacture, from access & delivery solutions for interventional medicine; to sensors & connectors for surgical applications. Our innovative solutions enable ground breaking medical therapies such as treating heart disease without opening the body, placing microscopic devices into brain arteries and powering robotic surgery.

Job Overview

Position is responsible for direct interaction and support of customer quality management, assuring that QSRs and QMS are in accordance with regulatory standards, and promote continuous improvement of the Quality System. Other duties may be assigned on an individual basis.

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Responsibilities

* Implementation of quality system documentation that is in compliance with the quality manual and associated Standard Operating Procedures (SOP's)

* Develop and execute to Validation Master Plans, Equipment Qualifications, Process Valdiations, 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

* Participating in design control activities to ensure that product meet specifications, reliability, and manufacturability

* Working knowledge of CAPA management to drive root cause analysis and practical corrective and preventative 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 knowlege of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies

* Work with suppliers fo both raw materials and components to improve product quality and/or resolve quality issues

Qualifications

* Min. Associate's degree, Bachelor's degree preferred

* Strong internship in medical device industry preferred

* Will consider 2 years' experience in industrial or mechanical engineering experience in any industry

* AQS certified preferred

* Excellent communication and interpersonal skills, proven problem-solving ability

Competencies

* Values: Integrity, Accountability,Teamwork, Innovation

Nearest Major Market: San Jose

Nearest Secondary Market: Palo Alto

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