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.

Responsibilities

• 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.
• 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.
• Aid 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.

Qualifications

• Bachelor's degree in manufacturing, industrial, mechanical, engineering, or related engineering technology field.
• Strong understanding of quality assurance principles, ISO standards, and manufacturing/production environments.
• Working knowledge of Quality Management Systems (QMS) and applicable standards such as ISO 9001 and/or ISO 13485, including CAPA management, audit administration (internal, regulatory, and customer), documentation control, and corrective action processes.
• Understanding of manufacturing processes, equipment, tooling, and production workflows, including troubleshooting, preventative maintenance concepts, and equipment implementation.
• Experience with time studies, work measurement, labor analysis, process mapping, and establishing production standards.
• Strong proficiency in Microsoft Excel (or similar tools) for data analysis, reporting, and cost modeling.

Skills

• Technical Knowledge - Strong working knowledge of G Suite and MS Office.

Benefits

• Continuing education and leadership development as well as tuition reimbursement
• Comprehensive health plan
• Generous paid time off (PTO) and paid holidays
• Sabbatical and parental leaves
• Life, dental, and vision insurance
• Short- and long-term disability plans
• Nationally recognized preventive health and wellness program
• Section 125 pretax health spending account, dependent care spending account, and premiums
• Retirement planning options with generous company % match
• Eligible for the Public Student Loan Forgiveness (PSLF) program