Reporting to the Quality Manager, the Quality Engineer role will be maintaining quality engineering programs, standards and improvements within the organization.
SHIFT: 6pm- 6am - Sun, Mon, Tue every other Wed
What a typical day looks like:
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.
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.
Holds up 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.
In charge of 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.
Explores reports and returned products and recommends corrective action.
Establishes program to evaluate precision and accuracy of production equipment and testing, measurement and research of equipment and facilities.
Approves product, process and equipment qualifications.
Provides liaison to various regulatory bodies.
The experience we're looking to add to our team:
Typically requires a bachelor's degree in engineering or equivalent experience and training.
2+ years of quality experience
2+ years of medical device industry or pharma industry experince/ ISO13485
CAPA, NCMRs experince
FDA regulated experience
What you'll receive for the great work you provide:
Is Sponsorship Available?
NoFlex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We 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).Quality Engineer • Austin, TX, US
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