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The Plant Quality Manager will be accountable to ensure the Quality Management System is implemented per requirements and to report areas of concern to Management. The Plant Quality Manager will be expected to ensure the plant remains in full compliance will regulatory requirements and ISO:13485 requirements as they pertain to the plant, customer specifications, and corporate quality procedures. This role will also be responsible for managing Quality department personnel at the site, including Quality Lab, Supplier Quality, Quality Engineering, and Site Cleanroom Monitoring and Control.

Promotes a safe working environment, complies with proper use of PPE, reports incidents, and participates in functional department safety meetings. Exhibits good environmental practices and procedures consistent with job(s) performed and EMS (Environmental Management System) requirements (ISO14644).

Job Functions:

Execution and oversight of a Quality Management System that operates in compliance with corporate quality policies and procedures, as well as relevant regulatory requirements (ISO:13485) and industry guidance. Execution of document control and review/approval of controlled documents. Execution and maintenance of ECO process including change management and review of all change controls. Execution and maintenance of supplier quality management and performance of supplier audits as appropriate. Complaint management including robust root cause analysis and CAPA. Ensure robust root cause analysis investigation and CAPA for deviations and nonconforming product. Implementation of an effective Internal Audit Program. Ensure adequate training program is in place. Oversight of applicable Validation Master Plan including equipment, process, product, sterilization, and test methods. Oversight of quality control laboratory and review/approval of quality control testing. Execution of cleanroom practices including qualification, monitoring, and behavior. Responsibility for Quality Risk Management in relevant aspects of the QMS. Responsible for maintenance and expansion of the Global QMS e-tool (ETQ) at the plant. Facilitate management review process including implementation of a metrics control plan to measure and monitor the health of the Quality Management System, Manufacturing System, and Supply Chain. Oversight and Maintenance of Site Sterility Program Customer Management including facilitating/hosting customer audits, ensuring robust and effective corrective action to customer audit observations, reviewing/approving quality agreements with customers, partnering in the resolution of quality issues and requests for information by initiating effective interdepartmental communication, managing ISO certification and maintenance of certification. Execute talent management activities with direct reports. Ensure proper performance management, training, and development of direct/indirect reports