Summary
Overview
Work History
Education
Skills
Timeline
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Stacy Nicolosi

Methuen,MA

Summary

Accomplished QA Complaint Coordinator Group Lead II at Werfen, adept in leading teams to enhance product quality and reliability, ensuring compliance with global standards. Expert in technical troubleshooting and fostering cross-functional collaboration, achieving a 95% complaint closure rate within 30 days. Proficient in SAP and renowned for exceptional organizational skills and effective communication.

Overview

27
27
years of professional experience

Work History

QA Complaint Coordinator Group Lead II

Werfen
Bedford, MA
08.2018 - Current
  • Lead the team to ensure the quality and reliability of Werfen products.
  • Ensure the quality and reliability of Werfen products in an effective complaint system that is compliant with FDA, ISO, and worldwide standards and regulations.
  • Collaborate with cross-functional teams and subject matter experts (SMEs) to ensure timely resolution of quality issues, and deliver high-quality output.
  • Root cause analysis for complex customer issues, including software, hardware, applications, methodology, reagents, quality control, proficiency failures, and calibrations.
  • Responsible for complaint review, ensuring timeliness for complaint management, and customer resolutions, with a 95% closure rate within 30 days.
  • Review of complaint investigation plans for execution, interpretation of results, and complaint file accuracy.
  • The lead for the product specific RAW process including assigning RAW lines for confirmed complaints, updating existing RAW lines and creating RAW lines for new failures.
  • Work closely with Regulatory Affairs to ensure potentially adverse events are reported within each countries timeline regulations.
  • Analyzed post-market surveillance data.
  • Train and mentor new existing employees on the team, resulting in improved team efficiency and customer satisfaction.
  • Implement metrics in SAP and Power BI to track, trend and report product quality issues.

Senior Technical Support Specialist

Werfen
06.2012 - 08.2018
  • Provided first-line technical support to customers, resolving complex issues and ensuring a high level of customer satisfaction
  • Utilized strong interpersonal communication skills and fast learning abilities to effectively address customer needs.
  • Troubleshoot complex technical issues including software, hardware, applications, methodology, reagents, quality control, proficiency failures and calibrations issues.
  • Proficient in data analysis including QC statistics, calibration, precision, and accuracy review
  • Served as a Subject Matter Expert guidance for new and existing team members in advanced technical issues for complex troubleshooting issues.
  • Authored department protocols, and training materials as needed.

Field Applications Specialist

Roche
05.2008 - 06.2012
  • Provided expertise in installing, utilizing, and troubleshooting complex medical technology applications.
  • Effectively communicated with customers and collaborated with internal teams to ensure the successful implementation and usage of Roche's products.
  • Performed validation studies including precision, linearity, and method correlations on complex Chemistry and Immunoassay instrumentation.
  • Performed data analysis utilizing EP Evaluator to build a customer-specific instrument verification manual.
  • Provided on-site customer training upon instrument installation and throughout instrument life including technical support to resolve customer issues related to applications, software, quality controls, reagents, proficiency failures and calibrations.
  • Served as liaison between customer and Sales, Marketing, and Technical Support to achieve and maintain a satisfied customer base.
  • Performed instrument demonstrations to assist Sales and Marketing.

Medical Technologist

Anna Jaques Hospital
Newburyport
02.1998 - 05.2008
  • Monitored and documented patient test results to ensure accuracy and compliance with established protocols.
  • Operated and maintained laboratory equipment used to perform clinical tests, resulting in improved accuracy and efficiency.
  • Performed complex testing on clinical specimens using automated analyzers and microscope analysis.
  • Trained and supervised junior medical technologists, resulting in improved accuracy and performance.
  • Implemented quality control programs to ensure accurate results and compliant with regulatory standards.
  • Performed CAP proficiency survey analysis to ensure accuracy and precision of laboratory results.

Education

Bachelor of Science - Medical Technology

University of Massachusetts

Bachelor of Science - Business Admnistration

University of Southern New Hampshire

Skills

  • Strong Organizational and multitasking Skills
  • Proficient in Microsoft Windows and SAP Software
  • Expertise of Werfen Hemostasis products including instruments, reagents, and applications
  • Effective written and oral communication skills
  • Excellent technical troubleshooting and critical thinking

Timeline

QA Complaint Coordinator Group Lead II

Werfen
08.2018 - Current

Senior Technical Support Specialist

Werfen
06.2012 - 08.2018

Field Applications Specialist

Roche
05.2008 - 06.2012

Medical Technologist

Anna Jaques Hospital
02.1998 - 05.2008

Bachelor of Science - Medical Technology

University of Massachusetts

Bachelor of Science - Business Admnistration

University of Southern New Hampshire

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Stacy Nicolosi