Job Description

Overview 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. Responsibilities 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. Qualifications 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 procedures manuals. Ability to work with mathematical concepts such as probability and statistical interference , and fundamentals of plane and solid geometry and trigonomentry. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations. Experience in Batch Record Review is required. Travel requirements: N/A Closing Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. #J-18808-Ljbffr UNAVAILABLE

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