Job Description:

Flex is a leading sketch-to-scale™ solutions company that designs and builds intelligent products for a connected world. With more than 200,000 professionals across 30 countries and a promise to help make the world Live Smarter™, the company provides innovative design, engineering, manufacturing, real-time supply chain insight and logistics services to companies of all sizes in various industries and end-markets. For more information please visit our careers page at www.flex.com. 

                      

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  Industry: Electrical / Electronic Manufacturing


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  Type: Public Company


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  NASDAQ: FLEX


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  Headquarters: 2 Changi South Lane, Singapore, 486123


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  Company Size: 10,001+ employees


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  Website: www.flex.com
  

*CURRENT EMPLOYEES :

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Job Description

The Software Quality Engineer will be based in Buffalo Grove, IL,. In this position you will be responsible for providing technical and implementations support for our Enterprise Integration Systems and applications. You will also be responsible for architecting, designing, installation, and set-up of our enterprise applications.

We are looking for someone who demonstrates:

• Intense collaboration


• Passionate customer focus


• Thoughtful, fast, disciplined execution


• Tenacious commitment to continuous improvement


• Relentless drive to win

Here is a glimpse of what you’ll do:

• Define, design, implement Validated systems in compliance with FDA specifications and Change control.


• Prepare Standard Operating procedures for the day-to-day maintenance of the applications and underlying systems.


• Ensure knowledge pertaining to new implementations and technologies are adequately shared with the team.


• Ensure adequate monitoring and controls are in place to ensure the stability of the solutions.


• Establish clear communication channels and ensure proper feedback mechanisms are in place with customers, peers and cross functional teams.


• Defining the validation strategy and implement Master Validation plan.


• Support to complete all the required Software Validation Deliverables


• Ensure and coordinates the proper execution of all Software Validation activities.


• Provides independent review and approve all the Software Validation deliverables generating during the Software Verification and Validation.


• Reviews protocols to determine if the proposed testing would adequately achieve the purpose of the protocol.


• Reviews executed protocols and reports for adherence with good record keeping practices and validation practices, and to determine if the conclusions drawn in the reports are justified.


• Provide guidance how to manage incident/defect handling.


• Support to identify and forecast the risk an issue with an appropriate solution.


• Experienced in corrective and preventive actions (CAPA) and writing validation reports (IQ/OQ/PQ).

Here is some of what you’ll need (required):

• BS in Information Technology, Computer Science, OR Equivalent work experience


• 5+ years of experience with software validation of enterprise systems


• Must have knowledge of IT environments and how to maintain applications


• Must have in-depth knowledge of FDA Part 11 and Part 820 regulations


• Outstanding Oral and Written communication skills with a high attention to detail

Here are a few of our preferred experiences:

• A demonstrated working knowledge of ISO 13485:9001, FDA, Medical Devices – Quality Systems and standards.


• Experience working in a manufacturing environment


• Knowledge of Automation machines

Here are a few examples of what you’ll get for the great work you provide:

• Full range of medical benefits, dental, vision


• Life Insurance


• Matching 401K


• PTO


• Tuition Reimbursement


• Employee discounts at local retailers

Job Category

Design, Process & Technology Engineering

Relocation

Is Sponsorship Available?

No

Flex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Flex does not discriminate in employment opportunities or practices based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status or any other status protected by law. Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. Please advise us of any accommodations you request to express interest in a position by e-mailing: accessibility@flex.com. Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with Flex.

The information we collect:

We may collect personal information that you choose to submit to us through the Website or otherwise provide to us. This may include your contact details; information provided in online questionnaires, feedback forms, or applications for employment; and information you provide such as CV/Resume. Your details will be provided to the entity you are applying for a job with. We will use your information for legitimate business purposes such as responding to comments or queries or answering questions; progressing applications for employment; allowing you to choose to share web content with others or; where you represent one of our customers or suppliers, administering the business relationship with that customer or supplier. We will process your data in accordance with our Recruitment Privacy Notice.

If you have any queries about the processing of your data, please contact:

 

Global Data Privacy Officer:

Email Address: chiefprivacyofficer@flex.com

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