Supervisor, Manufacturing Shop Floor Quality Assurance

Job Summary

The Supervisor, Manufacturing Shop Floor Quality Assurance leads day-to-day Quality oversight at the point of manufacture across incoming, in-process, final inspection, packaging, warehouse/shipping, and other assigned production activities. The role ensures manufacturing processes and materials conform to approved specifications and procedures through real-time floor presence, inspection, sampling, line clearance, AQL activities, and risk-based Quality decision making. The Supervisor leads Quality personnel assigned to shop-floor and inspection activities, ensures timely containment and escalation of deviations, nonconformances, product holds, and potential operational stoppages, and partners with Manufacturing to prevent quality issues while maintaining independent Quality authority.

The role supports—but does not own—the final DHR review/product-release process managed by the Manufacturing Quality Product Release function.

Key Accountabilities

• Lead, schedule, prioritize, coach, and develop Quality personnel assigned to shop-floor, incoming, in-process, final inspection, warehouse/shipping, and other designated Manufacturing Quality Assurance activities.
• Ensure appropriate staffing, work assignments, shift coverage, cross-training, and daily prioritization to provide reliable Quality support across required production schedules and operating hours.
• Oversee execution of line clearance, in-process inspections, sampling, AQL evaluations, final inspections, and other required Quality checks in accordance with approved procedures and specifications.
• Oversee incoming inspection activities, including receipt, sampling, inspection/testing coordination, status control, and disposition support for raw materials and components in accordance with approved procedures.
• Ensure timely containment and initiation of product holds, deviations, and nonconformances when product or process requirements are not met; escaltate issues outside delegated authority to MQA management.
• Ensure shop-floor Quality records and inspection documentation are accurate, complete, contemporaneous, and compliant with GDP and applicable procedures.
• Coordinate with Manufacturing and the Manufacturing Quality Product Release function to ensure inspection results, holds, deviations, nonconformances, and other release-relevant information are complete and available for DHR review and final product disposition.
• Support investigations and root-cause activities by providing shop-floor facts, records, samples, and Quality input, and ensure assigned follow-up actions are completed on time.
• Maintain daily inspection readiness within assigned areas and support internal audits, regulatory/notified-body inspections, and customer audits as requested.
• Reinforce adherence to approved procedures, Quality System requirements, company policies, and applicable regulatory and safety requirements; represent Manufacturing Quality Assurance in meetings and activities as delegated by the Sr. Manager, Manufacturing Quality Assurance.
• Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

Network with Manufacturing, Quality Laboratories, Manufacturing Quality Product Release, Quality Systems & Compliance, Quality Engineering, Supply Chain/Shipping, Warehouse/Receiving, and other applicable organizations to ensure effective shop-floor Quality oversight and timely escalation/resolution of product and process risks.

Minimum Knowledge & Experience required for the position:

• Associate’s degree (AA) or equivalent combination of education and experience.
• Quality Certification (i.e. ASQ Certified Quality Auditor), Root Cause Investigation Training; preferred
• Stay abreast of industry Best Practices and recommend, and/or participate in process improvement initiatives to keep Immucor in alignment with cGMPs.
• Previous experience with Quality Systems (FDA and ISO) in a regulated environment

Skills & Capabilities:

• Ability to Make sound, justifiable and risk based quality decisions in a timely manner, as appropriate
• Takes initiative and seeks opportunities for improvement in quality systems and overall department efficiency
• Demonstrated ability to follow instructions with minimal supervision.
• Ability to work independently and in a team environment
• Must be detail oriented and able to multi-task
• Ability to work in a fast paced…