Betty Ryan Email and Phone Number

CAPA and Quality Systems Remediation support

Support design teams through the design control lifecycle. Ensuring that all functional team members understand design control requirements and that D&D Plan deliverables are compliant to approriate processes. Represented the Andover, MA facility on the Draeger Global Council which manages the company-wide design control procedures for just under 3 years. Member of the Software Improvement Team that is responsible for evaluating and improving the software-related processes throughout Draeger world-wide.Certified Provisional SPICE Assessor.

Support teams and customers through the design process. Assist in updating the Quality Management System.

Manage Field Assurance (Complaint Handling) process.

Provide support to design team through the development process of new products. Manage TUV audits of 2 facilities, including followup on corrective actions related to those audits.Manage internal audit program and complaint system.Member of corporate internal audit program.Manage team responsible for merging the quality system of 3 facilities. The goal of this team was to prepare one quality system that would serve the needs of all three facilities allowing the organization to have one Quality System certifcation. Represent Regulatory Affairs on design teams for 3 years. Gain approval for seven (7) 510(k)s for new devices. Complete applicable international submissions for new products.