Remedy Intelligent Staffing, in partnership with a large medical devices manufacturer, is seeking an experienced Master Data Quality Specialist. This position is responsible for the establishment and ongoing compliance of processes related to Manufacturing Controls, Packaging and Labeling, and Incoming Inspection Quality System Elements. Responsible for the master batch record and supporting master data within the Quality System Elements. Ensures systems and processes are properly implemented and maintained for compliant execution and documentation of batch manufacture controls, incoming material controls, and product/material traceability.
Essential Job Duties:
- Responsible for establishing and maintaining the electronic batch record within the Manufacturing Execution System. Requires collaboration with Automation Engineering and Operations personnel to ensure compliance to all quality and regulatory requirements.
- Responsible for QA review of MES recipes and workflows, ensuring compliance to process, quality and regulatory requirements.
- Responsible for maintaining Quality master data for materials and inspection plans within SAP. Requires collaboration with Quality Control and Operations personnel to ensure compliance to all quality and regulatory requirements.
- Responsible for maintaining Quality master data within all existing data systems, as applicable, such as the Label Management System and Inventory Management System.
- Analyzes existing systems to improve upon vertical and horizontal system interfaces and efficiencies.
- Investigates and resolves system problems.
- Understands quality and regulatory requirements and integrates these within the company’s Quality Management System in accordance with system capabilities. Evaluates and implements system and process improvements to ensure that quality systems continue to meet regulatory requirements and expectations.
- Partners with Quality Operations on quality objectives related to quality systems and processes. Serves as a centralized team member for these initiatives. Ensures that user requirements are properly defined and documented, systems are structured to meet established requirements, and training is effectively provided to all affected personnel prior to implementation.
- Implements Corporate Operating Procedures and centralized processes and templates. Identifies and implements process improvement tools for Quality Systems to ensure the process requirements of Quality Compliance systems are integrated.
- Analyzes metrics and informatics to monitor the Quality System and its compliance. Identifies system and process issues, concerns or improvement opportunities and leads resolution.
- Ensures that the Company’s Quality System policies and procedures are developed, implemented and maintained in compliance with regulatory requirements. Incorporates best practices while maintaining alignment to Company Objectives.
- Keeps informed of all existing and new regulatory requirements and works with Quality Operations to ensure full compliance in the Company’s Quality Systems.
- Serves as a key quality systems expert to functional business units and Quality Operations.
- Travel to any company and/or vendor facility, domestic and internationally, when necessary.
- Keep abreast of changes in the regulations, interpretation of the regulations and revising internal practices and written procedures to comply with the regulatory requirements.