Quality Engineer

Quality Engineer

The "Quality Engineer" will be based in Austin, TX reporting to Adriana Russell.

What a typical day looks like:

Maintaining quality engineering programs, standards and improvements within the organization. The Quality Engineer (CAPA) is responsible for supporting and maintaining the effectiveness of the Quality Management System through ownership and oversight of Corrective and Preventive Action activities, quality investigations, root cause analysis, risk assessments, and continuous improvement initiatives. This role partners with cross-functional teams to ensure quality issues are thoroughly investigated, appropriately mitigated, and effectively resolved while maintaining compliance with applicable regulatory, customer, and organizational requirements.

The position serves as a key driver of quality system effectiveness, operational excellence, and regulatory compliance.

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

• Leads and facilitates Corrective and Preventive Action (CAPA) activities from initiation through closure, ensuring compliance with internal procedures, customer requirements, and applicable regulatory standards.
• Conducts thorough investigations using structured problem-solving methodologies such as 5 Whys, Fishbone Diagram, Fault Tree Analysis, Is/Is Not Analysis, and other root cause analysis tools.
• Evaluates quality system data, manufacturing metrics, audit findings, customer complaints, nonconformances, and trend analyses to identify systemic issues requiring corrective action.
• Ensures root cause investigations are scientifically sound, data-driven, and supported by objective evidence. Develops and initiates standards and methods for inspection, testing and evaluation.
• Develops, reviews, and approves correction, corrective action, and preventive action plans to address identified quality issues and prevent recurrence.
• Coordinates cross-functional teams including Manufacturing, Supplier Quality, Engineering, Regulatory Affairs, Operations, and Customer Quality to drive timely CAPA execution.
• Assesses quality events and nonconformances for CAPA applicability utilizing risk-based decision-making methodologies.
• 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.
• Participates in customer, internal, supplier, certification body, and regulatory audits and inspections.

• Typically requires a Bachelor's degree in related field or equivalent experience.
• Typically requires 6 years of experience in engineering in the high technology electronics industry or related field.
• Experience with Corrective and Preventive Action (CAPA), Nonconformance Management, Complaint Handling, Change Control, and Risk Management processes.
• Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements including FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Experience with electronic Quality Management Systems (eQMS) and quality data analysis tools.
• Strong project management, organizational, and communication skills with the ability to manage multiple priorities simultaneously.
• Experience supporting regulatory inspections, customer audits, and compliance activities preferred.
• Knowledge of medical device manufacturing, contract manufacturing, or highly regulated industries preferred.
• Demonstrated ability to influence cross-functional teams and drive quality improvements without direct authority.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations.
• Ability to apply mathematical operations to such…