Quality CAPA Engineer at Flex in Austin, Texas

Job Description:

Flex is the manufacturing partner of choice that helps a diverse customer base design and build products that improve the world. Through the collective strength of a global workforce across 30 countries and responsible, sustainable operations, Flex delivers technology innovation, supply chain, and manufacturing solutions to various industries and end markets. Create the extraordinatry: https://flex.com/careers. 

                      

• 
  Industry: Electrical / Electronic Manufacturing


• 
  Type: Public Company


• 
  NASDAQ: FLEX


• 
  Headquarters: 2 Changi South Lane, Singapore, 486123


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  Company Size: 10,001+ employees


• 
  Website: flex.com
  

*CURRENT EMPLOYEES :

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Job Description

The Quality CAPA Engineer  will be based in Austin, Texas. The Quality CAPA Engineer will be responsible to complete non-conformance (NCMR) or corrective and preventive (CAPA) investigation documentation to meet Flex standards and quality & regulatory requirements.

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:

• Provides support to operations and engineering in the identification of Root Cause and development of Corrective actions


• Responsible for reporting of yields and management of the Defect Reduction TeamSupports risk assessment documentation development


• Supports Device History Record review and approval


• Develops and initiates standards and methods for inspection, testing and evaluation.


• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data.


• Develops and implements methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility.


• Directs workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability.


• Compiles and writes training material and conducts training sessions on quality control activities.


• Supports Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues.


• Assures data availability and integrity for all quality related data.


• Consolidates and reports quality results.


• Initiates corrective action requests as needed and tracks to satisfactory completion.


• Assists with development and implementation of quality audits.


• Responsible for developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products.


• Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.


• Analyzes reports and returned products and recommends corrective action.


• Establishes program to evaluate precision and accuracy of production equipment and testing, measurement and analytical equipment and facilities.


• Approves product, process and equipment qualifications.


• Provides liaison to various regulatory bodies.

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

• 3 – 5 years’ experience working in manufacturing, engineering or quality assurance a GMP regulated or another regulated environment.


• Problem solving and critical thinking skills in order to be able to analyze data, critical thinking and ability to draw conclusions from data.


• Process based thinking and ability to analyze potential gaps in products or processes to determine root cause and corrective action.


• Advanced technical writing skills and ability to bring complex information together in an organized and clear way.


• Detail oriented with the ability to also make more broad connections with information and details.


• Experience with the requirements for cGMP medical devices and/or with ISO13485:2016 environment is preferred but not necessary.

Here are a few of our preferred experiences:

• BS in Engineering or similar degree

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

FG40

Job Category

QualityRelocation: Eligible for domestic relocation only

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.

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