Experience

Senseonics, Incorporated

• United States
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Senior Quality Engineer -Complaints

  • Aug 2021 - Present

  Review and evaluate all possible feedback received by Senseonics to identify whether a Senseonics customer complaint has been made. Responsible for processing complaints and incident (MDR, Vigilance) reports to assure that complaints are documented, reviewed, evaluated, investigated, and formally closed in a timely manner. Establish and maintain complaint files and databases for all customer complaints in accordance with U.S. and international regulations. Coordinate with Customer Service, Engineering, Quality, and any complaint investigation and analysis personnel to gather root cause determinations and properly document complaint closure. Possible involvement with and/or support of internal and external audits of activities related to handling and documenting customer complaints. Maintain an understanding of information/data required to be collected for technical and AE complaints to assure compliance with regulations and directives. Show less



Theragen

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Specialist

  • Apr 2019 - Aug 2021

  Ensure all activities are carried out in compliance with local, federal and international regulations. Ensure that new and revised documents are approved as per procedures in a timely manner. Set up and manage (in support of Operations and R&D) Device Master Records and Device History Files. Lead the documentation and tracking of product complaints (including conducting an initial investigation) and any resultant CAPAs. Act as Management Representative by providing support for audits and inspections and identifying improvements to the system, procedures and work practices. Show less



Parsons Corporation

• United States
• Professional Services
• 700 & Above Employee

• Document Control Coordinator

  • Nov 2018 - Apr 2019

  Plans, organizes, and implements systems for efficient document processing of all communications, contractor documents, design documents, construction documents or other internal or external documents. Will have knowledge of both the work processes of document control and also the use of electronic systems used to manage documentation. Coordinates the flow of documents between project operations, engineering disciplines, construction team, or other functional groups. Manage required construction project documentation in a SharePoint based environment. Show less



SeaSpine

• United States
• Medical Equipment Manufacturing
• 300 - 400 Employee

• Document Control Coordinator

  • Jan 2018 - Jun 2018

  Identify and submit product attributes to the FDA Global Unique Identification database (GUDID)./ Manage master data, including the Global Trade Identification Numbers (GTIN), for every product./ Manage, maintain process and distribute controlled documents and records to ensure compliance with regulations (i.e. FDA QSR/GMP, ISO 13485) and corporate and/or site procedures./ Compile and scan Device Master Record (DMR), Device History Record (DHR), Device History File (DHF) and any additional documentation. Show less

• Regulatory Affairs Coordinator

  • Mar 2015 - Jan 2018

  Publish Premarket Submissions and Technical File (Hard copy & eCopy)./ Organize and maintain company regulatory documentation to assure it is accurate, up-to-date and readily available to appropriate personnel and during an audit or inspection./ Ensure that SeaSpine is appropriately registered with every Federal and State governing body.



Integra LifeSciences

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Field Inventory Control Specialist

  • Oct 2014 - Dec 2014

  Execute field inventory control processes, variance analyses, and inventory reconciliations. Execute field inventory control processes, variance analyses, and inventory reconciliations.



Delaware County, Pennsylvania

• United States
• Government Administration
• 300 - 400 Employee

• Fiscal Officer I

  • Jul 2013 - Jul 2014

  Train & supervise the Fiscal Eligibility unit to ensure compliance to Federal and State regulations./ Track & monitor federal, state and county funding./ Communicate with other County staff to question and verify information used to complete federal funding determination.

• Fiscal Technician -Team lead

  • Aug 2008 - Jul 2013

  Maximize Federal funding to aid in the reimbursement of costs incurred by Delaware County for at-risk children. My duties included, but not limited, to maintaining an extensive knowledge and an accurate interpretation of Federal procedures and regulations.



AVI Foodsystems

• United States
• Food and Beverage Services
• 700 & Above Employee

• Management Intern

  • Jan 2008 - May 2008

  Conceive and initiate the Management Internship program. I’m responsible for the management of finance, sales, and training for 10 venues within the system. Duties include managing the purchase of supplies and tracking of inventory; assisting in the review and preparation of payroll, audits, deposits, daily receipts reports, and annual budget; assist in the analysis and processing of daily sales reports for all venues; and with planning and conducting sales and general training. Conceive and initiate the Management Internship program. I’m responsible for the management of finance, sales, and training for 10 venues within the system. Duties include managing the purchase of supplies and tracking of inventory; assisting in the review and preparation of payroll, audits, deposits, daily receipts reports, and annual budget; assist in the analysis and processing of daily sales reports for all venues; and with planning and conducting sales and general training.