Manufacturing Quality Assurance (QA) Assistant Manager

About the role

This is a M-F leadership position located on the west side of downtown Indianapolis at 413 N Tremont St, Indianapolis, IN 46222.

Responsibilities

• 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.
• Led inspection process development and standardization, ensuring processes are efficient, repeatable, and aligned with quality requirements.
• 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.

Qualifications

Required Competencies:

• Degree and Credential Requirements - NONE!
• 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 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 world.
• Data Review and Reporting - Collects, interprets, and examines operational data to identify root causes, resolves corrective actions, and continuously improves processes.
• Planning and Prioritization - Manages competing demands by effectively organizing issues by relevance considering operational objectives and customer service excellence. Excellent time management, planning, scheduling, and coordination skills. Can work in a highly structured environment and quickly adapts to changes in priorities or deadlines while maintaining a positive attitude. Effectively navigates complex situations to ensure that tasks are completed on time and to a high standard.
• 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 issues.

Benefits

Full-time employees may participate in a comprehensive benefits program that includes:

• 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
• Retail planning options with generous company % match
• Eligible for the Public Student Loan Forgiveness (PSLF) program