Manufacturing Quality Assurance (QA) Engineer

About the role

This position is based at our 38th and Sheridan location on the northeast side of Indianapolis (address is 6130 E. 38th Street, Indianapolis, IN 46226) and will need to travel to our other locations on the west side of Indianapolis and Bloomington as needed. The general salary range is $68-$80K and includes full benefits (below). The Quality Assurance Engineer is a high-impact individual contributor responsible for ensuring product quality, process integrity, and compliance within manufacturing operations. This role serves as a key partner to Manufacturing and Operations leadership, integrating quality assurance principles into production processes while driving continuous improvement, operational efficiency, and regulatory compliance. This position plays a central role in the administration and execution of the Quality Management System (QMS), including ownership of CAPA processes, audit programs (internal, regulatory, and customer), and quality data analysis. The role bridges quality systems and manufacturing execution by supporting the QMS, leading quality-focused process improvements, and providing technical expertise across production, equipment, and new product introductions. Additionally, this role acts as a primary liaison for customer quality coordination and audit readiness, ensuring strong communication, responsiveness, and alignment with customer expectations. This position reports to the Quality Assurance Director. Example Duties and Activities Maintain and administer the Quality Management System (QMS) in alignment with ISO 9001 / ISO 13485 standards, including development and control of quality policies, procedures, work instructions, and documentation. Own CAPA (Corrective and Preventive Action) processes, including CAPA administration, tracking, effectiveness verification, and timely closure. Lead root cause analysis and ensure systemic corrective actions are implemented and sustained. Plan, conduct, and administer the internal audit program, including audit scheduling, execution, reporting, and follow-up on findings to ensure compliance and continuous improvement. Support and lead participation in external audits, including regulatory audits and customer audits, ensuring audit readiness, coordination, and successful outcomes. Serve as a primary point of contact for customer quality coordination, including communication of quality issues, audit support, corrective action responses, and ongoing relationship management. Monitor, analyze, and report quality metrics and statistics, including trend analysis of nonconformances, CAPAs, complaints, and production data to identify risks and drive data-driven decision-making. Partner closely with Manufacturing, Engineering, and Operations leadership to embed quality standards into production processes and daily operations. Support job set-ups by developing and maintaining work instructions, process documentation, and standardized production methods. Conduct time studies, job analysis, and yield evaluations to establish efficient, quality-focused production standards and support quoting activities. Provide technical support to troubleshoot product, process, and equipment-related issues, ensuring timely resolution and minimal disruption to operations. Assist in new product introductions by developing quality plans, inspection criteria, and process controls to ensure successful implementation. Lead and implement Lean and continuous improvement initiatives focused on enhancing quality, safety, productivity, and cost efficiency. Recommend and support process improvements, including workflow optimization, facility layout, material handling, and equipment justification with a quality-first approach. Partner with production teams to ensure equipment performance aligns with quality standards, including preventative maintenance practices, troubleshooting, and new installations. Collaborate with external vendors and technical partners on equipment, tooling, and process improvements as needed. Design or recommend fixtures, tools, and process enhancements to improve product consistency and operational efficiency. Develop and deliver training to production staff on quality standards, procedures, and best practices to reinforce a culture of quality and accountability. Support cross-functional collaboration with Business Development and Operations by providing input on labor analysis, production feasibility, and cost estimates. Participate in Management Review and cross-functional initiatives to align quality objectives with overall business goals and customer expectations. Required Competencies Degree and Credential Requirements - Bachelor's degree in manufacturing, industrial, mechanical, engineering, or related engineering technology field. Industry Expertise - Strong understanding of quality assurance principles, ISO standards, and manufacturing/production environments. Working knowledge of Quality Management Systems (QMS) and applicable st

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