Diane Smith Email & Phone Number

Dover, Delaware, United States

As the Operations Superintendent I am responsible to ensure compliance with safety policies and practices in EPC, delivering expected results in TIR, safety audits, and training, as well as compliance with quality systems in Fem Care. It involves reducing process variation using improvement tools like SPC and Kaizen, in collaboration with various departments. Additionally, leading housekeeping efforts and 5S adherence, supporting Tier communication, and overseeing labor costs and efficiencies are essential. Leading Continuous Improvement/Lean projects, implementing cost reduction programs, and providing weekly cost reviews with corrective actions are part of the responsibilities. Modeling Edgewell's values, fostering teamwork, and promoting high performance among hourly colleagues are also crucial aspects of the role.

Dover, Delaware Area

In this role, I was responsible for quality assurance group that monitors product performance through various sources, improves customer satisfaction and addresses product issues through risk evaluation and product actions. Interfaces with broad range of internal functional groups including operations, R&D, marketing, and planning and serves as quality liaison with Division and Corporate functions including Medical Event Group, Product Quality Assurance, and related functions. Maintains exceptional communication with Senior Quality Assurance Manager and other senior business leaders on issues.Furthermore I am responsible for communications with external regulators (FDA) as it applies to job responsibilities and represents the organization during internal and external audits in multiple areas including QA operations, complaint management, risk evaluation, and vigilance activities when needed. Responsibilities also include advising senior management regarding action plans for events related to product quality and product safety.In addition, serves as a key quality representative for Corrective Actions to review and ensure appropriate content is documented in nonconformance and deviation reports. Make key decisions on product quality issues and provides oversight for product non-conformance situations ensuring adequate investigation and corrective actions are in place to prevent future occurrences. Also ensures non-conformances meet the requirements listed within the procedures; investigations are completed and product disposition is consistent with the conclusions of the documentation.

Dover, Delaware Area

In this role, I have provided supervisory support for Quality Management System (QMS) and sustained the quality policy and culture for the FDA in the manufacturing of medical devices. Responsible for quality assurance, control processes, and programs by developing, implementing, and administering quality standards and procedures assuring product quality, continual improvement, and customer satisfaction. Managed all aspects of the Device History Records department, ensuring all records are complete and accurate, properly filed, secured, and controlled, as well as approve manufacturing lots for QA release.As a QMS Representative ensured compliance to customer, regulatory, and business requirements while being involved in Training program, requirements, and compliance also managing standard practices for Quality processes. Developed, monitored, and maintained Quality Metrics (includes customer satisfaction interaction) also she drove product and process quality improvement using function appropriate tools (i.e. CAPA, audit, etc.) while ensuring quality participation and providing quality inputs.Ensured Quality team involvement in applicable product planning & manufacturing release processes and ensured management and control of non-conforming material/product process including compliance to applicable QMS documentation and communication of QMS effectiveness. Developed sampling inspection plans using ANSI/ASQC Z-1.4, identifying critical points in the manufacturing process and specified sampling procedures to be used at these points.

Dover, Delaware Area

In this role, I developed quality strategies to achieve business objectives while ensuring compliance with regulatory requirements. Implemented and managed programs across the business unit to ensure improved customer satisfaction and compliance with regulatory requirements; monitored customer complaint and service activity to address adverse trends that may impact customers and business and provided feedback into product improvement initiatives using internal and external data. Effectively translated customer needs into product and process requirements; reviewed process and product designs to ensure that customer needs are met; identified issues affecting customer satisfaction and established initiatives to address those issues and prevent defects.Furthermore, managed area consistent with long term business strategy; developed policies and procedures to implement and helped shape the business strategy; initiated communication programs to ensure that strategy is communicated and known. Was responsible for conducting routine tasks within the quality assurance program comprised of data review ad confirmation of results against known standards and performed work crucial to the control, security, integrity of documents and data associated to the review and release of products.Reviewed and approved Device Records in support to final product release;issued nonconformance’s related to documentation and products; generated certificates of analysis for products when applicable; performed records management and record retention activities for documents and quality standards;and ensured data collected during testing and manufacturing are accurate and complete.

Bachelor’S Degree, Bachelors In Organizational Management, Gpa 3.9

Bachelor’S Degree, Bachelors In Project Management, Gpa 3.9

Education record