Device History Record (DHR) Reviewer 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. 

                      

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  Industry: Electrical / Electronic Manufacturing


• 
  Type: Public Company


• 
  NASDAQ: FLEX


• 
  Headquarters: 2 Changi South Lane, Singapore, 486123


• 
  Company Size: 10,001+ employees


• 
  Website: flex.com
  

*CURRENT EMPLOYEES :

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Job Description

The Device History Record (DHR) Reviewer​ will be based in Austin TX. (F - 600p-600a)

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 guidance and assistance to support teams in development of Device History Record processes and forms


• Acts as a Subject Matter Expert for Device History Record (DHR) processes


• Support active resolution for production issues as it relates to DHR Completion (i.e. non conformances and CAPAs)


• Support the activities to review batch records, compile the DHR and approval of in-process product and finished goods.


• Support in-process and final product release for high volume medical device product


• Provides immediate quality support to the manufacturing line to document and address concerns


• Supports screen and purge activity, as needed


• Audits processes, tests and inspects products and/or develops, compiles and evaluates statistical data to determine and maintain quality and reliability of products.


• Working from engineering drawings, specifications, schematics, diagrams, written descriptions, layouts or defined plans to perform complex engineering testing, checkout, First Article Inspection, root cause analysis, internal corrective actions and supplier correction actions.


• Interprets engineering drawings, schematic diagrams or formulas and confers with management or engineering staff to determine quality and reliability standards.


• Selects processes to be audited from primarily the manufacturing areas and checks for a variety of features, including ESD (electro-static discharge) and handling practices, documentation, training and process integrity.


• Selects products for audits at specified stages in the production or post-production process, and tests products for variety of qualities such as dimensions, performance and mechanical, electrical or cosmetic characteristics.


• Records audit data, applying statistical quality control procedures.


• Evaluates data and writes reports to validate or indicate deviations from existing standards.


• Recommends modifications of existing quality or production standards, programs or reports to achieve optimum quality within limits of equipment capability.


• Perform calibration on inspection tools e.g. micrometers, calipers height gages etc.


• Maintain gage track program, print list of gages due for calibration in the beginning of each month and follow up with calibration.


• Send gages out for calibration, maintain calibration records


• Prepares graphs or charts of data or enters data into computer for analysis.


• Download quality information from quality system to be used for DHRs.


• Performs out of box audits (OBA), as required


• Provides factory support to identify and resolve issues associated with purchased parts, materials, and manufacturing.


• May be required to perform inspection.

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

• Requires a High School Diploma or equivalent, technical training, or equivalent experience.


• Typically requires a minimum 2-4 years of related experience


• FDA knowledge


• CFR-21


• Strong Excel and Word

Here are a few of our preferred experiences:

• Medical Devices

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

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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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