Quality Engineer

To 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 to maintaining quality engineering programs, standards and improvements within the organization.

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

• 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.

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

• Bachelor’s degree in related field or equivalent experience.

• 3+ years of experience as a Quality Engineering in the medical devices industry.

• Experience working on CAPA´s & DHR

• Advanced skills in Microsoft Excel and PowerPoint for data analysis and presentation.

• Customer facing experience.