Sandy Dobs Email & Phone Number

Morrisville, Nc, Us

Wayne, Pa, Us

Manage dynamic teams within Teleflex Shared Services; External Standards and Regulations, Document Control, and Training. Develop team members to achieve high potential in their career paths. Function as facility Lead for both internal and external audits. Interact and manage relationships with notified bodies and customers for customer audits.Key member of team aligning acquisition companies into a single Quality Management System (QMS) structure. Provide feedback and updates to colleagues during Technical Review of QMS documents at both the local and global levels.Manage metrics for Change Management and Training.Manage training department conversion to ComplianceWire training platform for QMS training.Manage Change Management activities within the Oracle Agile Product Lifecycle Management (PLM) system.Global Records Management responsibility for QMS and non-QMS records.

Wayne, Pa, Us

Manage Document Control, Labeling, and Training departments within the Teleflex Morrisville, NC facility. Manage own brand labeling, UDI compliance, quality system harmonization activities, participate in internal and external audits with notified bodies and regulatory agencies. Manage global quality system documentation, design history file information, and quality system training personnel.

Wayne, Pa, Us

Manage a team in the Document Control, Graphic Design and Labeling Administrative/Support areas. Interface with colleagues in a variety of capacities throughout Teleflex US locations, as well as outside purchased finished goods vendors and international Teleflex colleagues to assure consistent and compliant documents and labeling for medical device products. Exercise skills in critical thinking and problem solving. Initiate process improvement of a manual labeling change process and promote integration of documentation and labeling within an acquisition environment. Business Lead for a major labeling model change to implement a template-based labeling approach managing label content via an ERP database, enabling efficient processing of mass labeling updates (e.g. address, symbology). Core team member on a project team to bring an eDMS solution to Teleflex Labeling, Document Control, and Training. Manage various Labeling compliance projects, such as bringing labeling into compliance with MDD requirements. Participate on global Labeling committees and projects. Core team member to implement a global conversion to GS1 standards and implementation of UDI requirements for Teleflex Medical devices.

New Brunswick, Nj, Us

Managed document, design, and change control activities for a combination product (drug / device). Key activities included establishing process and procedures for review and approval of design requirements and changes to both the drug and device portions of the product. Developed and performed quarterly corporate training on internal design control procedures as related to 21 CFR 820.30. Provide supervision to Document Control associates. Provide support during internal and external regulatory audits. Focus on continuous improvement to processes.

Bachelor Of Science (Bs), Business Management

Associate Of Arts (A.A.), Liberal Arts And Sciences/Liberal Studies