Stacey Cribb
Roselle Park,NJ
Summary
Results-driven Engineer I at Getinge with a decade of expertise in managing product complaints and ensuring compliance with MDR and Vigilance reporting. Proficient in data analysis and cross-functional collaboration, I excel in delivering timely resolutions and maintaining regulatory standards while effectively supporting project managers and leading complaint investigations.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Engineer I, Complaint Handler
Getinge
Wayne, NJ
05.2016 - Current
- I am currently employed as an Engineer I/ Complaint Handler with an extensive background in Complaint Handling from start to finish.
- I have been involved in the Complaint Process for 10 years, with a plethora of knowledge of Complaint Handling from start to finish.
- I have worked on cross function teams to collaborate on certain projects as well able to independently function to get results under a Consent Decree.
- I have provided support and assistance in the evaluation of Product Complaints for Medical Device and Vigilance reporting.
- In this role, I have a complete understanding of the Overall Complaint Process, vigilance reporting, ROW reports, EMDrs, as well as Complaint Investigations that involve hands on investigation of returned products as well as non-return products.
- Responsible for reporting of complaints, and timely submission of MDR reports to the FDA.
- Provide support and assistance in the evaluation of Product Complaints for Medical Device Report (MDR) and Vigilance (MDV) reports.
- Responsible for reporting of complaints and processing of trending.
- Manages intake of medical devices for evaluation.
- Document failures as observed, updates the complaint with necessary information from accounts, sales representatives, hospitals.
- Inspecting the product for reported and as analyzed failure.
- Intake and gathering information from the accounts to better report the event to the FDA.
- Maintain the upkeep of investigation labs.
- Conducting investigations in a timely matter to submit reports to the FDA or necessary reporting authority.
- Ability to work in a team environment with members of the QA-Product Surveillance group on achieving team, as well as independently.
- Metrics requirements under a Consent Decree.
- Effectively work independently and with different parts of the organization to resolve complex issues.
- Excellent computer and data analysis skills.
- Ensure timely closure of complaints to comply with the FDA requirements and other regulatory bodies and structures.
- Responsible for intake of product complaints, which includes, but not limited to, taking photographs of product.
- Trained in: Trackwise, CATSweb, SAP, Windchill, CAPA, HHE, PNCR.
LPN- Product Complaint Analyst
Premiere Response-Johnson & Johnson-Ethicon Account
North Bergen, NJ
01.2014 - 04.2016
- Provide support and assistance in the evaluation of Product Complaints for Medical Device Report (MDR) and Vigilance (MDV) reports.
- Responsible for reporting of complaints and processing of trending analysis in accordance with Corporate, Site, and department procedures, and regulatory requirements.
- Manages intake of medical devices for evaluation.
- Document failures as observed, updates the complaint with necessary information from accounts, sales representatives, hospitals.
- Manage & review product complaints utilizing and interfacing with electronic systems such as Remetrex and SIEBEL.
- Manage the review and extraction of medical records from Adverse Event litigation complaints files and summons related to bio-surgery medical devices.
- Responsible for database searches and inquiries of medical records of litigation complaint cases.
- Accountable for all product complaints from inception to closure, including corrective follow ups.
- Support Project Managers on various projects as required.
- Work independently with minimal supervision, and as a team.
- Siebel and Remetrex CHATS training, Excel, Microsoft Outlook and Microsoft Word.
Staff LPN
Robert Wood Johnson
Carteret, NJ
12.2013 - 05.2014
- Performed medical assessments on members, including BP, weight, measurements and performing BMI analysis and hydration status.
Staff LPN
Family Medical Center
Woodbridge, NJ
10.2013 - 11.2013
- Daily responsibilities included, setting up a PFT machine and administering ordered tests by the doctors, performing Phlebotomy when lab tests were ordered, assisted the Allergy Doctors with allergy testing and administration of serums, placed EKG's when ordered.
Staff LPN
Cornell Hall
Union, NJ
07.2013 - 09.2013
- G-Tube, TPN Feeding
- Wound care experience
- Collection of specimens for ordered tests
- IV experience
- Foley Catheter.
Staff LPN
Bethany Pediatrics/Meridian Health
Hazlet, NJ
05.2010 - 05.2013
- Acquiring patient health information (height, weight, blood pressure, pulse, temp)
- Administer ordered vaccinations to patients
- Administer Nebulizer treatments as ordered
- Assist doctors when needed in removal of sutures
- Triage phone nurse
- Assist in maintaining/updating patient charts.
Staff LPN
Union Pediatric Medical Group
Union, NJ
10.2007 - 05.2010
- Acquiring patient health information (height, weight, blood pressure, pulse, temp)
- Administer ordered vaccinations to patients
- Administer Nebulizer treatments as ordered
- Assist doctors when needed in removal of sutures
- Triage phone nurse
- Assist in maintaining/updating patient charts.
Education
Diploma - Nursing
Union County College
Cranford, NJ01.2007
Skills
- Manage product complaints
- Review product complaints
- Interfacing with electronic systems
- Database searches
- Extraction of medical records
- Support Project Managers
- Work independently
- Team collaboration
- Siebel
- Remetrex
- Excel
- Microsoft Outlook
- Microsoft Word
- Complaint handling
- MDR reporting
- Vigilance reporting
- Product evaluation
- Data analysis
- Cross-functional collaboration
- Root cause analysis
- Trend analysis
- Time management
- Task prioritization
- Deadline driven
Certification
- Lean Six Sigma Yellow Belt, 10/2018
- Complaint Handling, 12/2024
Timeline
Engineer I, Complaint Handler
Getinge
05.2016 - Current
LPN- Product Complaint Analyst
Premiere Response-Johnson & Johnson-Ethicon Account
01.2014 - 04.2016
Staff LPN
Robert Wood Johnson
12.2013 - 05.2014
Staff LPN
Family Medical Center
10.2013 - 11.2013
Staff LPN
Cornell Hall
07.2013 - 09.2013
Staff LPN
Bethany Pediatrics/Meridian Health
05.2010 - 05.2013
Staff LPN
Union Pediatric Medical Group
10.2007 - 05.2010
Diploma - Nursing
Union County College
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