Quality Engineer

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Job Summary

The Quality Compliance Engineer (ESD) will be based in Austin, Texas reporting to Paul Gilly.

What a typical day looks like:

Responsible for developing, implementing, and sustaining site-wide regulatory compliance programs with a primary focus on Electrostatic Discharge (ESD) control in accordance with ANSI/ESD S20.20 and applicable quality standards (e.g., ISO 9001, AS9100, TL9000, 13485). The site subject matter expert for the ESD and Regulatory Agency Compliance programs, leading audit execution, regulatory interface, CAPA systems, and continuous improvement initiatives. The Quality Compliance Engineer collaborates cross-functionally with Operations, Engineering, Quality, and external stakeholders to ensure audit readiness, minimize compliance risk, and implement scalable, data-driven solutions that support business objectives while maintaining strict regulatory adherence.

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

• Own and maintain site ESD Control Program in alignment with ANSI/ESD S20.20 requirements.

• Interpret regulatory standards and translate them into practical, auditable procedures. (ESD, ISO, Agency UL, CSA, TUV, etc.)

• Maintain controlled documentation including procedures, work instructions, and compliance records

• Serve as primary point of contact for regulatory bodies, customers, and external auditors

• Ensure ongoing audit readiness across all assigned sites and operational areas

• Develop and manage internal ESD audit schedules across multiple sites/modules

• Lead execution of internal ESD audits, ensuring consistency, objectivity, and risk-based focus

• Prepare sites for external certification and surveillance audits

• Generate formal audit reports with clearly defined findings, severity classifications, and required actions

• Present audit results, trends, and risk assessments to senior leadership

• Define and maintain CAPA trigger criteria based on defect severity, recurrence, and risk

• Lead root cause analysis and ensure appropriate corrective and preventive actions are implemented

• Review and approve CAPA closures based on effectiveness verification

• Ensure alignment between audit findings, defect codes, and compliance risk levels

• Continuously refine CAPA thresholds to balance compliance rigor with operational efficiency

• Develop and maintain compliance tracking systems (e.g., Microsoft Lists, databases, dashboards)

• Analyze audit data to identify trends, systemic issues, and improvement opportunities

• Build automated reporting and visualization tools (e.g., Power BI dashboards)

• Normalize audit data (e.g., defects per audit or exposure) for accurate performance evaluation

• Provide leadership with actionable insights to drive decision-making

• Partner with Operations to implement compliant solutions that minimize production impact

• Coordinate with Calibration teams to ensure proper testing and equipment validation

• Collaborate with IT/software teams to develop or enhance compliance tools and automation

• Support Engineering and Manufacturing with ESD risk assessments and mitigation strategies

• Communicate compliance expectations and results across all organizational levels

• Develop and maintain ESD and compliance training materials

• Train technicians, engineers, and operators on compliance requirements and procedures

• Ensure training programs are standardized, scalable, and audit-defensible

• Drive adoption of compliance tools and systems across the organization

• Identify gaps in compliance processes and implement sustainable improvements

• Lead initiatives to modernize systems (automation, digital tracking, workflow integration)

• Streamline compliance processes to reduce administrative burden while maintaining rigor

• Benchmark program performance and implement best practices across sites

• Support expansion of compliance programs to new areas or business units

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