Experience

ActiveProtective

• United States
• Computers and Electronics Manufacturing
• 1 - 100 Employee

• Quality Manager

  • Dec 2021 - Present

  Overseeing building of QSR compliant Quality System and medical DHF for the Tango Belt. Overseeing building of QSR compliant Quality System and medical DHF for the Tango Belt.



Nu Skin

• United States
• Retail Health and Personal Care Products
• 700 & Above Employee

• Manager - Consumer and Medical Devices, and Regulatory Operations

  • Jul 2019 - Present

  Manage collection and reporting of global regulatory requirements, certification, and global market access for Nu Skin's consumer and medical devices. Responsible for certification and ISO 14971 Risk Management File. Managed global regulatory processes and systems, including sharepoint library for submission dossier, Workfront project management, and Nintex workflows for Regulatory Product Updates, Post-Market Surveillance, Claims Approval, and Change Control

• Regulatory Specialist

  • Sep 2017 - Jul 2019

  Manage collection and reporting of global regulatory requirements, certification, and global market access for Nu Skin's consumer and medical devices. Responsible for certification and ISO 14971 Risk Management File. Managed global regulatory processes and systems, including sharepoint library for submission dossier, Wrike project management, and Nintex workflows for Regulatory Product Updates, Post-Market Surveillance.Given Pinacle Employee recognition award for overcoming obstacles to complete certification of a medical device and launch on time. Show less

• Quality Engineer

  • Apr 2016 - Sep 2017

  Managed Quality needs for Nutriceuticals and Foods, including Supplier Qualfication Audits and For-Cause Audits in multiple countries, including China, Japan, Taiwan, Korea, France, and Norway. Responsible for internal and supplier CAPA. Responsible for internal and supplier process improvements, usually triggered by NCR, including proper equipment inspection, pouching machine set up, etc. Responsible to complete Quality work to develop new product, and successfully launched a gummy-supplement. Show less

• Customer Complaint Specialist III

  • Sep 2014 - Apr 2016

  Investigated customer complaints and adverse events; assisted in process improvement projects. Given Pinacle employee recognition award for proposing, developing and implementing a risk-based method to triage complaints, significantly reducing the number of investigations.

• Quality Assurance Specialist

  • Sep 2013 - Sep 2014

  Inspected product and certificates of analysis against specification; inspected devices for warranty credit; processed customer returns