Manufacturing Quality Assurance (QA) Engineer

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 Activitie

• s 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 documentatio
• n.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 sustaine
• d.Plan, conduct, and administer the internal audit program, including audit scheduling, execution, reporting, and follow-up on findings to ensure compliance and continuous improvemen
• t.Support and lead participation in external audits, including regulatory audits and customer audits, ensuring audit readiness, coordination, and successful outcome
• s.Serve as a primary point of contact for customer quality coordination, including communication of quality issues, audit support, corrective action responses, and ongoing relationship managemen
• t.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-makin
• g.Partner closely with Manufacturing, Engineering, and Operations leadership to embed quality standards into production processes and daily operation
• s.Support job set-ups by developing and maintaining work instructions, process documentation, and standardized production method
• s.Conduct time studies, job analysis, and yield evaluations to establish efficient, quality-focused production standards and support quoting activitie
• s.Provide technical support to troubleshoot product, process, and equipment-related issues, ensuring timely resolution and minimal disruption to operation
• s.Assist in new product introductions by developing quality plans, inspection criteria, and process controls to ensure successful implementatio
• n.Lead and implement Lean and continuous improvement initiatives focused on enhancing quality, safety, productivity, and cost efficienc
• y.Recommend and support process improvements, including workflow optimization, facility layout, material handling, and equipment justification with a quality-first approac
• h.Partner with production teams to ensure equipment performance aligns with quality standards, including preventative maintenance practices, troubleshooting, and new installation
• s.Collaborate with external vendors and technical partners on equipment, tooling, and process improvements as neede
• d.Design or recommend fixtures, tools, and process enhancements to improve product consistency and operational efficienc
• y.Develop and deliver training to production staff on quality standards, procedures, and best practices to reinforce a culture of quality and accountabilit
• y.Support cross-functional collaboration with Business Development and Operations by providing input on labor analysis, production feasibility, and cost estimate
• s.Participate in Management Review and cross-functional initiatives to align quality objectives with overall business goals and customer expectation

s.
Required Competenci

• es Degree and Credential Requirements - Bachelor's degree in manufacturing, industrial, mechanical, engineering, or related engineering technology fie
• ld.Industry Expertise - 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 process
• es.Project and Process Management - 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 standar
• ds.Technical Knowledge - Has strong working knowledge of G Suite and MS Office. Strong proficiency in Microsoft Excel (or similar tools) for data analysis, reporting, and cost modeling. Experience with ERP/MRP systems preferr
• ed.Communication Skills - Articulates thoughts and expresses ideas effectively using oral, written, visual, and non-verbal communication skills, as well as listening skills to comprehend customers' needs. Delivers information in person, in writing, and in a digital wor
• ld.Building Collaborative Relationships - Develops, maintains, and strengthens partnerships at all levels with others inside or outside the organization who can provide information, assistance, and support. Is able to receive as well as provide feedback to improve performance or processes; builds and maintains customer satisfaction and is adept at vendor negotiati
• on.Innovation - Creates new and better ways for the team to be successful by identifying gaps, evaluating opportunities, assessing risks, and putting ideas into acti
• on.Critical Thinking and Problem Solving - Uses both rationale and reasoning to examine data, processes, and strategies in identifying trends and inconsistencies to create alternative solutions, conclusions, or approaches to problems. Implements innovative solutions to address complex issu

es.
Benefits: Full-time employees may participate in a comprehensive benefits program that inclu

• des:Continuing education and leadership development as well as tuition reimburse
• mentComprehensive health
• planGenerous paid time off (PTO) and paid holi
• daysSabbatical and parental le
• avesLife, dental, and vision insur
• anceShort- and long-term disability p
• lansNationally recognized preventive health and wellness pro
• gramSection 125 pretax health spending account, dependent care spending account, and prem
• iumsRetirement planning options with generous company % m
• atchEligible for the Public Student Loan Forgiveness (PSLF) pro