Name: Becky Addy

Location: Maple Shade, NJ (will work remotely)

Contact: 614-***-****

Email: ad1vgm@r.postjobfree.com

Availability for Interview: Immediately

Availability to Start: Immediately

Education:

Bachelor’s in social and Instructional Psychology, Minor: Geography from University of Cape Coast

Master’s in healthcare administration, Midway University

Experience with Post Market Surveillance/ Complaint Handling:

Has 7+ years of experience working in complaint handling and MDR file documentation in accordance with regulatory requirements; global complaint handling and adverse event reporting activities; reviewing and managing deviation investigation; Corrective and Preventive actions documentation (CAPA).

Documentation:

Experience in Documentation and cGMP. Documented product complaints into Quality Management Systems database for trending and responsible for investigating, completing, and maintaining Complaint Records in timely and accurate manner in accordance with the FDA's QSR Regulations, ISO 13485 and Quality Systems Regulations (21 CFR Part 820), the MDD and department requirements as appropriate.

Quality Management Systems:

Proficient in TrackWise, SharePoint Quality Management System, Enterprise Quality Management System - EtQ, Tableau, SmartSolve, LMS, GSMS C2C and learning management system.

Skills:

• Demonstrated strong written and verbal communication skills.

• General computer skills (MS Excel, Word, PowerPoint, database) as well as working experience of SharePoint and MS Teams.

• Efficient independent worker with ability to focus.

• Attention to detail.

• Demonstrated cross functional communication skills in email and in person.

• Organizational and analytical skills.

• Ability to handle and manage workload independently and prioritize numerous activities in a rapid paced environment.

• Contribute to team-oriented tasks.

• Analytical skills.

• Interpersonal and decision-making skills.

• Detail oriented and strong administrative skills including time management.

Competency / Training:

• Demonstrated ability in performing general and basic regulatory reporting for Medical Devices and complaint system and process requirements for post market surveillance.

• Demonstrated understanding of general and basic quality records requirements and how they apply to complaint files and regulatory reports.

• Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.

Experience:

Rang Technology: Intuitive Surgical Contract Assignment Jan/2023 – Sept/2023

Product Complaint Associate

Acted as primary notification and consolidation point for receiving, processing, analyzing and reporting product complaints.

Developed and updated company complaint and inspection procedures to ensure capture and investigation of complaints.

Maintained and analyze problem logs to identify and report recurring issues to quality assurance management and product development.

Documented and track contact information reported issues and problems in accordance with company guidelines and external regulatory requirements.

Collaborated with other internal groups to respond to product inquiries and issues.

Directly answered telephone, hot line and written or Internet-based inquiries regarding company products.

Performed daily complaints investigations.

Performed the preliminary classification of complaints and escalate complaints that require additional review.

Performed Failure Analysis investigation review and escalate complaints that require additional review.

Filed Malfunction MDR Reports as identified.

Escalated Adverse Event or Incident reports as identified.

Evaluated documentation for completeness and consistency and assign additional actions as necessary to close the complaint file.

Managed complaint workload to required backlog goals.

Reviewed and analyze lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.

Escalated complaints to the Regulatory Post Market Surveillance Manager or Lead when new failure modes are encountered.

Escalated complaints to the Post Market Investigation (PMI) group as required.

Evaluated complaints for reporting requirements in accordance with company procedures and Regulatory requirements.

Interfaced with Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMA.

Participated in new hire training and continuous Regulatory Compliance training as required.

Participated in process improvement activities to continuously improve process effectiveness.

Executed on projects as required.

Performed other duties as directed including assisting with training new employees.

Infosoft: Siemens - Contract Assignment Oct/2022 - Jan/2023

MDR Complaint Analyst/Quality Engineer

Evaluated safety complaint escalations, make decisions on MDR reporting, and documenting those decisions.

Filed MDRs when needed and communicate (as appropriate) to the Authorized Representative or Regional Unit.

Work with members of other teams to review, assess, and close potentially adverse events (pMDRs), including MDR reporting related to IMMULITE systems/ADVIA Chemistry systems/ADVIA Centaur Systems/Automation/ Dimension systems / Dimension Vista systems/Informatics systems.

Provided support in all areas associated with MDR/MDVR/MDPR reporting and trending.

Supported the Commercial Product Quality (CPQ) department when working on post market IMMULITE systems/ADVIA Chemistry systems/ADVIA Centaur Systems/Automation/ Dimension systems / Dimension Vista systems/Informatics systems related issues from the Escalation Review Council (ERC).

Provided CPQ support for the above-mentioned systems Product Health Teams.

Displayed a high level of critical thinking in bringing successful resolution to high-impact, complex, and/or cross-functional problems is expected.

Demonstrated significant knowledge of organization's business practices and issues faced and contributed to problem resolution of those issues.

Sunrise Systems Inc.: Kimberly Clark – Contract Assignment Jan/2021 -, Apr/2022 – Oct/2022

Quality Consultant IV

Executed assigned Post-Market Surveillance activities, including Complaint Assessment, Investigation, Trending/Reporting, Final Review, and Sample Evaluation. Flow to Work to assist others as needed.

Responsible for providing Post-Market Surveillance support to assigned Mills and/or Product Forms via Standard Work, data analysis, and communication. Responsible for completing Level 1 & 2 Complaint Investigations on behalf of Mills.

Executed continuous improvement plans for the assigned sub-system(s) to deliver business results.

Maintained relationships with Consumer Services, including reporting of and troubleshooting errors, and coordinating complaint handling activities and improvements.

Built and maintained capability within the assigned sub-system for compliance with QMS, ISO, and FDA GMP's.

Ensured activities and items were in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements.

Maintained and demonstrated an appropriate level of knowledge and skill in product forms, quality systems, processes, and regulations.

Apolis: Becton Dickenson – Contract Assignment, Franklin Lakes, NJ Jul/2020 – 12/2020

Post Market Surveillance Specialist

•Collaborate with appropriate clinical, technical, and/or regulatory employees to determine product event status and MDR reportability.

•Assure timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for BD products.

•Write and submit eMDR reports to the FDA and Health Canada in strict adherence with regulatory requirements and timelines.

•Coordinate, research, and prepare correspondence in response to FDA and global regulatory agencies requests for additional information.

•Maintain complaint and MDR file documentation in accordance with regulatory requirements. Completes global complaint handling and adverse event reporting activities related to BD products.

•Comply with the site Quality System.

LTTS: Phillips-Contract Assignment Edison NJ Oct 2017 – June 2020

Complaint Handling Specialist (Post Market Surveillance Analyst)

Responsible to determine FDA reportability of Complaints in a remediation setting.

Coded complaints based on previously performed investigations in Trackwise and SAP.

Revised investigation summaries based on any new information available.

Data mining and Quarrying experience.

Handled the receipt, processing, monitoring, and reporting of product defect complaints, Make MDR determination, investigate and document all activities creating the summaries of the investigation.

Documented product complaints into the database for trending and analysis and ensured the complaint process was completed in accordance with corporate procedures, follow the complaint file all the way until completion.

Developed professional expertise, apply company policies and procedures to resolve a variety of issues. Interfaces with Customer Service and customers/patients to gather additional information required for complaint initiation/investigations, including the retrieval of product samples and or durable equipment retrieval for evaluation, ensures that complaints from multiple sources are tracked.

Determined product and incident complaint codes based on the master symptom code severity list.

Applied knowledge of device regulatory requirements in order to support the Post Market Clinical Surveillance reporting process and evaluates complaints for reporting, partners with other departments to resolve product problems.

Assisted with review of the timely coding of completed investigations, closure of all complaint files, and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure.

Performed queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints. Reviews and complies with all applicable company policies and procedures, local, state, and federal laws and regulations.

CAPA support in response to audit readiness findings and in preparation for audits. Coordinate initiative to close out overdue Field Change Orders with global markets. Provide team members with training on a variety of assignments.

Nobel Biocare, Mahwah, NJ Aug 2016 - Sep 2017

Complaint Handling Specialist (Post Market Surveillance Analyst)

Responsible for investigating, completing, and maintaining Nobel Biocare Complaint Records in timely and accurate manner in accordance with the FDA's QSR Regulations, ISO 13485/9000/9001, the MDD and departmental requirements as appropriate.

Evaluated incoming data to determine if sufficient information was available to understand the nature of the complaint and initiate an investigation. Sorted investigations by product line, complaint type, and root cause for Review and Reporting. Additionally, maintained customer complaint data and files in support of internal and 3rd party audits.

Reviewed and evaluated all possible complaints received to identify whether a customer complaint had been made and determine whether an investigation is required.

Performed adverse event reportability determinations for complaints in accordance with U.S. and international regulations.

Coordinated with Customer Service, Regulatory, Quality, and other complaint investigation personnel to gather root cause determinations and properly document complaint closure.

Coordinated with Regulatory Affairs to ensure that all complaints were properly evaluated for U.S. and international adverse event reporting.

Evaluated documentation for completeness and consistency, resolved issues with missing information, and assign additional actions as necessary to close complaints.

Ensured complaints were processed thoroughly and timely in compliance with departmental procedures and metrics.

Utilized Corrective and Preventive actions (CAPA), to eliminate and prevent causes of undesirable situations with regards to the proper use and management of the company's products.

Ensured that BOM for dental restorative and impression materials lasted until the expiration date at controlled room temperatures. To prevent temperature excursions. Since higher room temperatures 27º - 32º C (80º - 90º F) may reduce the working times for the materials, making them unacceptable for use.

Electronically and manually maintained device history record (DHR) also known as batch record to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the overall requirements of the FDA QSR.

Thoroughly reviewing and managing deviation investigations

Mindlance: Medtronic (Covidien) -Contract Assignment Jan – Oct 2015

Document Control - Complaint Handling Specialist (Post Market Vigilance Analyst)

Closely monitored quality and timelines of complaints files.

Provided present data trend to other departments as necessary.

Ensured obligations to internal/external customers are being performed in an accurate and timely fashion.

Run weekly reports and enforce timely closure of investigations/plant engineering investigations.

Liaised with plant engineers, project managers on a monthly /as needed basis to assure all trending is appropriately communicated throughout the organization.

Document control management.

Ad hoc reporting.

Contact this candidate