DHR Quality Engineer

Job Posting Start Date 01-29-2024 Job Posting End Date

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 Quality Engineer located in Austin, TX.

Reporting to the Quality Manager the DHR Quality Engineer role maintains quality engineering programs, standards, and improvements within the organization, with a direct focus on Device History Record activity.

What a typical day looks like:

• Responsible for the management and tracking of Device History Records and associated procedures, templates, and tools
• 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 processes
• May support a team of DHR reviewers, and provides training and guidance for that team
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Compiles and writes training material and conducts training sessions on quality control activities.
• Supports Product Engineers and Quality Managers with customer interfaces as necessary on quality related issues.
• Support active resolution for production issues (i.e., nonconformances, CAPAs, deviations)
• Assures data availability and integrity for 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.
• Supports Compliance (ISO) and Regulatory (FDA) audits
• Develop and implement performance metrics.

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

•  2+ years Quality Engineering experience
• Manufacturing experience
• CAPA (Corrective and Preventive Actions) and NCMR (non-conformance material report) experience
• Experience working in a regulated environment
• Prefer medical device industry experience

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

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).