Mary Wall Email & Phone Number

Princeton, New Jersey, US

Princeton, New Jersey, US

• Worked across various product stages including new product introduction, manufacturing operations, and post market surveillance to ensure compliant manufacturing of Class II implantable medical devices.
• Provided quality support to remediation of entire manufacturing process and site Quality Systems including assessing risk involved in new processes, assessing quality compliance, and writing documents such as SOPs and.
• Lead cross-functional teams through complex product quality investigations.
• Authored and owned two CAPA investigations to each address both an FDA Warning Letter Citation and 483 Observation, through the verification of effectiveness phase.
• Lead audit back room and provided front room support for over 400 audit hours, including a 12-week FDA inspection.
• Authored risk assessments for Health Hazard Evaluations, product complaint investigations, non-conformance investigations, and CAPAs.

Princeton, New Jersey, US

• Owned the Post Market Surveillance complaint investigation process for the site, completing failure analysis on devices, analyzing risk management documentation to assess the effect on patients, and working to.
• Owned planned deviation process, working with deviation owners to create, execute, and close planned deviations to site procedures and coordinated the quality systems documentation.
• Authored non-conformance investigations to determine and correct the causes of various manufacturing issues, as well as assisted in managing the site-wide non-conformance system and material review board.
• Participated in external audits by fielding incoming requests from auditors in the backroom.
• Worked with cross-functional team to author two Health Hazard Evaluation reports to evaluate the risk to patients of products that do not conform to regulatory requirements.

Bad Homburg, Frankfurt, DE

• Processed dozens of daily product inquiries and complaints for devices and drugs manufactured and distributed by Fresenius Medical Care.
• Investigated and analyzed product events for safety and regulatory compliance by liaising with customers, healthcare professionals, product manufacturers and distributors to collect information.
• Made regulatory reporting determinations on whether Medical Device Reports or Field Alert Reports were required for device and drug complaints.
• Interfaced with quality engineering team and manufacturing sites to return suspect products and samples and collect the necessary information to complete failure analysis.
• Worked with strict deadlines to ensure all regulatory timelines were met.

Boston, MA, US

• Managed and maintained thousands of pieces of medical equipment using equipment management database as well as installed and maintained software and security of the computers in the MGH operating rooms.
• Provided on-call IT help for Epic medical records software, medical equipment connected to hospital network, Windows OS, permissions to hospital systems, and communication devices.
• Led project to replace over 80 Windows PCs and adjoining mounting hardware on anesthesia machines.
• Supported vendors to implement a new real-time location tracking system for medical equipment and decommissioned dozens of old location-tracking sensors