• Design Assurance representative for remediation project regarding documentation within Windchill system• Core team Design Assurance Representative for a Mechanical Thrombectomy System• Participated in animal study to address safety concerns with a Mechanical Thrombectomy System• Manage Risk management activities and associated documentation• Design Assurance Representative for First in Human Clinical Studies

• Maintained QMS for Qorvo Biotechnologies in MN and Texas- this includes owning and maintaining all Quality Systems SOPs • Acted as Management Representative in the front room of audits• Managed and owned CAPAs and Nonconformances• Manage Notified Body correspondences• Managed all audits (internal and external)• Conducted Management Review, Product Health meetings and Material Review Board (MRB).• Oversaw all new product development from a quality perspective, including… Show more • Maintained QMS for Qorvo Biotechnologies in MN and Texas- this includes owning and maintaining all Quality Systems SOPs • Acted as Management Representative in the front room of audits• Managed and owned CAPAs and Nonconformances• Manage Notified Body correspondences• Managed all audits (internal and external)• Conducted Management Review, Product Health meetings and Material Review Board (MRB).• Oversaw all new product development from a quality perspective, including risk management activities• Customer Quality Engineering representative- interfaced with Clinical Sites related to instrument• Manufacturing Quality Engineering representative- Involved in Quality decision making regarding deviations and nonconformances• Management Delegate for Quality• Voting member on Change Control Board for all major and minor product, process and software changes• Supported and reviewed all Validation Activities including IQ/OQ/ PQs for instrument and software validations• Reviewed and approved drawings, SOPs and validation documents though internal systems Show less

• Obtained ISO 13485 certification for Qorvo Biotechnologies in MN and Texas• Organized software audit and worked with a team to ensure all non-conformances were closed through CAPA• Attended and completed audit based software validation course• Managed all CAPAs• Front room audit leader• Improved Biotechnologies Quality Manual by putting it into an ISO 13485:2016 format and updating it to current practices• Completed manufacturing walk throughs to identify gaps between… Show more • Obtained ISO 13485 certification for Qorvo Biotechnologies in MN and Texas• Organized software audit and worked with a team to ensure all non-conformances were closed through CAPA• Attended and completed audit based software validation course• Managed all CAPAs• Front room audit leader• Improved Biotechnologies Quality Manual by putting it into an ISO 13485:2016 format and updating it to current practices• Completed manufacturing walk throughs to identify gaps between current state and ISO 13485: 2016 compliance• Completed gap assessments for standard changes• Created and updated Quality Plans, Procedures and Work Instructions• Reviewed DHRs, DMRs, and DHFs• Review and approve drawings, SOPs and validation documents through internal systems. Show less

• Subject Matter Expert (SME) for the Quality Management System• Compiled and reviewed batch record documentation supporting release of finished pharmaceutical products• Created, reviewed and approves QMS documents• Front room support for Notified Body, Internal and FDA audits• ISO 13485: 2016 certified Lead Auditor • Created metrics for CAPAs, Complaints, Deviations/NCRs to be presented at monthly feeder meetings, Quarterly Metrics Review and Management Review

As Quality Analyst II at TE Connectivity my primary job responsibilities include: managing the CAPA system, participating in leading ISO13485, AS9100 and ISO9001 audits and perform quality trending for the Andover Sensor Solutions Site. In my position I work closely with Regulatory Affairs, Design/Manufacturing Engineering and Customer Care.

In this role I analyzed and investigated incoming safety and quality complaints and assessed them for notified body reportability. I also led a cross functional escalation meeting to organize R&D testing, PLRAs, CAPAs and Field Action reports.

-Purification of specific antibodies from animal serum or cell culture material through affinity and adsorption column chromatography using both automated and manual systems -Perform High Performance Liquid Chromatography (HPLC)-Perform Reverse Radial Immunodiffusion (RRID), isoelectric focusing (IEF), immunoelectrophoresis (IEP) -Perform Biuret testing-Perform annual preventative maintenance and enrolled new lab equipment -Aid in Method Comparison for new assay development… Show more -Purification of specific antibodies from animal serum or cell culture material through affinity and adsorption column chromatography using both automated and manual systems -Perform High Performance Liquid Chromatography (HPLC)-Perform Reverse Radial Immunodiffusion (RRID), isoelectric focusing (IEF), immunoelectrophoresis (IEP) -Perform Biuret testing-Perform annual preventative maintenance and enrolled new lab equipment -Aid in Method Comparison for new assay development with Research and Development-Write Investigational reports, comply with Standard Operating Procedures and update them as necessary using Quality and Regulatory’s guidance as well as using good documentation processes-Participated in a Shingijitsu Kaizen to improve the manufacturing process in our warehouse. Also, participated in Value Stream Mapping events to identify muda. Show less

Worked in Dr. Ahmed Heikal's biophysical research laboratory. I researched cellular macromolecular crowding effects on transport and interactions using fluorescence correlation spectroscopy (FCS) to be used in pharmaceutical studies. See publication.