Quality Control Manager

The Quality Control Manager is a hands-on individual contributor responsible for overseeing daily Quality Control activities at Indianapolis site. The role manages receiving inspection, batch record review, final product release, nonconforming material activities, quality events, supplier quality, calibration coordination, labeling controls, and QC documentation. This position serves as the Indianapolis site representative during internal and external audits and regulatory inspections and works cross-functionally with Quality Assurance, Operations, Engineering, Regulatory Affairs, and Supply Chain.

Supervisory responsibilities may be added as the function grows.

Key Duties & Responsibilities

• Manage receiving inspection activities, including verification of materials, components, documentation, and labels.
• Review batch records and exercise final product release authority after confirming that applicable requirements have been met.
• Review and approve Certificates of Conformance, Certificates of Analysis, and other applicable release documentation.
• Lead NCMR and Material Review Board activities, including product holds, disposition decisions, meeting facilitation, documentation, and follow-up.
• Investigate and document quality events and determine when escalation to CAPA or another formal quality-system process is required.
• Support supplier qualification, supplier scorecards, performance monitoring, and supplier corrective-action activities.
• Create and maintain QC procedures, work instructions, inspection methods, sampling plans, acceptance criteria, and quality specifications.
• Review and approve ECOs and DCOs within assigned areas of responsibility.
• Support new product introductions, process transfers, and reviews of QC-related technical-file content.
• Coordinate calibration activities for company assets and maintain control of inspection equipment.
• Manage label inspection, UDI label creation and release, and maintenance of approved label templates.
• Maintain quarantine controls, material-status identification, rejected-material disposition records, and retention or reference samples when required.
• Serve as the Indianapolis site representative for internal and external audits, customer audits, and regulatory inspections.
• Maintain complete and accurate QC and eQMS records in accordance with data-integrity, documentation, and retention requirements.
• Monitor QC workflows, overdue records, and established turnaround times and escalation delays or risks as needed.
• Prepare and present monthly and quarterly QC metrics, identify adverse trends, and recommend corrective or improvement actions.
• Track pest-control and cleaning records and follow up on incomplete or overdue documentation.
• Plan and prioritize QC workload, identify resource needs, and support QC-related training when needed.
• Participate in cross-functional quality activities with Quality Assurance, Operations, Engineering, Regulatory Affairs, Supply Chain, and external suppliers.

Education/Experience

• Bachelor's degree in science, engineering, quality, or a related technical field, or an equivalent combination of education and relevant experience.
• Minimum of five years of progressive quality experience in the medical-device industry.
• Hands-on experience with receiving inspection and batch record review and product release is required.
• Experience with NCMR/MRB, CAPA, supplier quality, quality events, ECOs, DCOs, calibration, UDI labeling, or eQMS workflows is preferred.
• Prior supervisory or team-lead experience is preferred but not required.