Job SummaryTo support our extraordinary teams who build great products and contribute to our growth, we're looking to add a
Quality Engineer located in
Austin, TX.Reporting to the Quality Manager, the
Quality Engineer will be maintaining quality engineering programs, standards and improvements within the organization.
Shift: Austin - E - 600a-600p Sun,Mon,Tue,every other Wed What a typical day looks like:- Facilitate and lead customer-focused meetings to address quality and performance concerns.
- Manage and resolve quality issues including nonconformances, CAPAs, and deviations.
- Provide technical support for validation activities and ensure compliance with regulatory standards.
- Lead discussions on Good Manufacturing Practices (GMP) and drive process improvement initiatives.
- Organize and lead meetings focused on yield enhancement and scrap reduction strategies.
- Support Device History Record (DHR) investigations and related documentation.
- Oversee and execute risk management activities to mitigate potential quality and compliance risks.
- 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 related field or equivalent experience.
- 4 years of quality engineering experience
- 2 years of medical device experience / ISO13485
- Previous manufacturing experience
- FMEAs, CAPA, Roots cost analysis, Lean six sigma tools experience
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
Application Deadline:
Applications for this job position will be accepted for at least five days following the job posting start date below and continuing until the end date below or until the position is filled. This posting may close sooner due to application volume.
Job Posting Start Date 06-16-2026 Job Posting End Date
Job CategoryQuality
Is Sponsorship Available?
No
