Manager, Manufacturing Quality Product Release

Job Summary

The Manager, Manufacturing Quality Product Release leads the Manufacturing Quality Assurance prod-uct-release function for the Norcross site. The role is accountable for timely, compliant review of Device History Records (DHRs) and associated manufacturing documentation and for execution of product dispo-sition and release activities within delegated Quality authority. The Manager develops and leads DHR Re-view Specialists and Quality Associates, establishes standard work and performance metrics for right-first-time review and release, and partners with Manufacturing, Quality Laboratories, Supply Chain, Regulatory Affairs, Quality Systems & Compliance, and Quality Engineering to resolve release barriers without com-promising product quality or compliance.

The role maintains inspection readiness for product-release rec-ords and actively supports regulatory/notified-body and customer inspections.

Key Accountabilities

• Lead, coach, mentor, and develop the Product Release team, including DHR Review Specialists and Quality Associates; establish clear expectations for quality, compliance, service, training, and right-first-time performance.
• Manage day-to-day DHR/batch record review and product release activities, including staffing, prioriti-zation, standard work, and coverage to support manufacturing and shipping requirements
• Ensure manufacturing batch records, electronic records, test results, release documentation, and re-quired approvals are complete, accurate, traceable, and compliant before product disposition and re-lease.
• Execute or ensure execution of final product disposition and release activities within delegated Quality authority and promptly escape product-quality, compliance, or release risks requiring higher-level de-cisions.
• Drive timely resolution of documentation discrepancies, deviations, exceptions, holds, and other re-lease barriers with the appropriate process owners; ensure release-impacting quality records are ap-propriately assessed before disposition.
• Establish and maintain product-release standard work, including review checklists, escalation criteria, release controls, reconciliation processes, and contingency processes for business-system interrup-tions.
• Monitor product-release performance using appropriate metrics, including DHR review cycle time, backlog/aging, right-first-time quality, documentation errors, and release timeliness; address recurring issues through the applicable Quality System processes.
• Maintain inspection readiness for DHR and product-release processes and records; represent the function during regulatory/notified-body, customer, and internal audits.
• Partner with Manufacturing, Quality Laboratories, Supply Chain, Quality Systems & Compliance, De-sign/Sustaining Quality Engineering, and Regulatory Affairs to resolve release barriers while preserving independent Quality decision making.
• Participate in operational and Quality tier meetings to communicate release status, priorities, emerging risks, decisions needed, and recovery plans, ensuring timely escalation at the appropriate level.
• Foster a culture of patient safety, quality, compliance, accountability, right-first-time execution, and continuous improvement while ensuring adherence to company policies, SOPs, and applicable regula-tory requirements.
• 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, Quality Systems & Compliance, Design & Sustaining Quality Engineering, Regulatory Affairs, Supply Chain/Shipping, Warehouse/Receiving, Information Technology/business systems, and other applicable organizations to ensure compliant and timely product disposition and release.

Minimum Knowledge & Experience required for the position:

• Bachelor’s degree (BS/BA) from four-year college or university; or equivalent combination of education and experience.
• Four-year scientific/technical degree or 5 plus years of experience in a comparable manufacturing environment is required to ensure sound judgment and performance, preferred
• Experience/certification as a medical technologist is preferred

Skills & Capabilities:

• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations. Ability to write reports, business correspondences and…