Manufacturing Quality Assurance (QA) Supervisor- 38th and Sheridan

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Additional Information

This is a M-F leadership position located on the northeast side of Indianapolis (address is 6130 E. 38th Street, Indianapolis, IN 46226). The general salary range is $50-$60K and includes full benefits (below). The Quality Assurance (QA) Supervisor provides leadership and administrative oversight of the Quality Management System (QMS) in alignment with ISO 9001 and ISO 13485 requirements. This role operates as a key extension of QA Management, focusing on system governance, audit leadership, investigation oversight, and data-driven decision-making rather than routine inspection activities. The Supervisor leads core quality system processes, including internal audits, customer complaint investigations, CAPA/NCR systems, and document control. This role ensures quality processes are structured, compliant, and continuously improving while partnering cross-functionally to drive resolution of quality issues. Acting as a liaison between production, management, and QA leadership, the Supervisor ensures alignment of quality objectives, facilitates management review inputs, and provides structured insights to leadership. The position is responsible for supervising QA personnel through delegation, coaching, and performance management while maintaining strong ownership of training systems, compliance programs, and quality metrics. This position reports to the Quality Assurance Director. Example Duties and Activities Provides leadership and oversight of the QMS to ensure ongoing compliance with ISO standards, focusing on system effectiveness and sustainability. Partners with QA Management to implement, maintain, and improve quality policies, procedures, and site-level work instructions. Leads and oversees the internal audit program, including planning, auditor coordination, execution, and reporting of findings. Oversees customer complaint investigations, ensuring timely root cause analysis, documentation, and resolution aligned with regulatory and customer expectations. Manages and supports CAPA and NCR investigations, including tracking, documentation, effectiveness checks, and closure. Reviews and approves quality system documentation, including procedures, work instructions, and records to ensure compliance with GDP and ISO requirements. Leads inspection process development and standardization, ensuring processes are efficient, repeatable, and aligned with quality requirements. Oversees calibration administration, ensuring equipment is maintained, calibrated, and documented per applicable standards. Coordinates environmental testing programs, including administration, monitoring, and trending of results to identify risks and improvement opportunities. Prepares and compiles inputs for Management Review, including quality metrics, audit results, trends, and improvement recommendations. Supervises QA staff, including assigning work, monitoring performance, conducting evaluations, and providing coaching and development. Develops and coordinates training programs related to QMS, ISO requirements, and quality standards for QA staff and cross-functional teams. Ensures availability and accuracy of translated quality documentation (e.g., Spanish) to support workforce understanding and compliance. Acts as a cross-functional partner with Operations, Engineering, and other departments to align quality objectives with operational goals. Reviews quality data and trends to identify systemic issues and drive continuous improvement initiatives. Supports new program launches and process changes by ensuring quality system readiness and compliance requirements are met. Required Competencies Degree and Credential Requirements - NONE! We value candidates who can demonstrate capability and articulate how prior experiences will help them contribute. We believe in continuous learning and professional development. People Management - Directs supervisory and management of staff to ensure the success of personnel and division goals. Quality Standards and Methodologies - Expertise in quality assurance base standards, requirements, specifications, and guidelines to ensure that products, services, and processes are of good quality and fit for purpose according to ISO 13485 and ISO 9001. Possesses practical experience with continuous improvement methodologies such as TQM, FMEA, etc. 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. Customer Focus - Ability to see, comprehend and relate with customers in an impartial, unbiased yet effective and balanced manner; builds and maintains customer satisfaction with the products and services offered by the organization; provides excellent service to internal and external customers. Communication Skills - Articulates thoughts and expresses ideas effect

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