Device History Record (DHR) Reviewer - Night Shift

Job Posting Start Date 06-25-2024 Job Posting End Date 07-30-2024

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.

We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives.

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a DHR Reviewer located in Austin, TX.  

Reporting to the DHR Manager, the DHR Reviewer role involves providing guidance and assistance to support teams in development of Device History Record processes and forms.

Schedule: 600pm-600am Sun, Mon, Tues, Every other Wed (15% shift diff)

What a typical day looks like:

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

The experience we’re looking to add to our team:

• Requires a High School Diploma or equivalent, technical training, or equivalent experience.
• Typically requires a minimum 2 years of related experience.
• FDA and/or medical device knowledge preferred.
• 21CFR
• Experience using Excel and Word

What you’ll receive 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

#LI-TK10

Job Category

Quality

Relocation: Not eligible

Is Sponsorship Available?

No

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate 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. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).