Quality Engineer

Discovered

Flex

Austin, TXexternalScience and EngineeringPosted over 1 year ago (Apr 2, 2025)

About the role

Job Posting Start Date 04-01-2025 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. @@HD@@ Job Summary@@/HD@@ @@HD@@ The Quality Engineer@@/HD@@ will be based in

Austin, Tx

, reporting to

Quality Manager.

In this role, you will be maintaining quality engineering programs, standards and improvements within the organization. @@HD@@ Shift - E -6 am-6pm- Sunday, Monday, Tuesday every other Wednesday @@/HD@@ @@HD@@ What a typical day looks like:@@/HD@@ • Develops and initiates standards and methods for inspection, testing and evaluation, also disposition for discrepant materials. • 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. • Assures data availability and integrity for all quality related data. • Initiates corrective action requests as needed and tracks to satisfactory completion. • Assists with development and implementation of quality audits. • Approves product, process and equipment qualifications. • IDE and Clinical trials applications in accordance with MDD Annex X, ISO 14155 standard • Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards. • An excellent understanding and practical application of medical device quality system regulations, e.g., 21 CFR 820, ISO 13485 and ISO 14971

The experience we're looking to add to our team

• 4 years of Quality Engineer - Manufacturing process knowledge • 2+ years of FDA Standards, ISO 13485, medical devices experience • Previous CAPA, NCMRs, Root cost analysis experience • Technical training and experience using Statistics, Lean and Six Sigma Methodologies required • ASQ CQE, CRE, CSQE certification (prefer) • Supply quality experience ( prefer)

What you'll receive for the great work you provide

• Full range of medical, dental, and vision plans • Life Insurance • Short-term and Long-term Disability • Matching 401(k) Contributions • Vacation and Paid Sick Time • Tuition Reimbursement

Job Category

Quality 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).

Not published in this posting

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