Ally Roettgers Email & Phone Number | I was an influential part of two remediation teams where I gathered information to help create change logs, scope documents, and clinical history memos. As part of a quality assurance initiative I helped in the closure of gaps that were found during the process of Design History File remediation. This included compiling sales and complaint data to ensure all risk mitigation's had been addressed and were below a certain occurrence level. I updated DFMEA's of the provisional instruments and the cases used for the launch of a new implant. I also assisted in supporting a new product development launch from the perspective of similar device analysis and meeting current regulatory requirements related to risk management.I managed a Pre-Release Product Review in the final stages of launching to ensure that all specifications and tolerances were met from development to packaging checks. I assisted in the implementation for more efficient processes for Zimmer's packaging plant in Puerto Rico. I managed two of the clean rooms to ensure production was running smoothly and producing the output per hour that we expected. I documented comparative analysis risks to previous medical devices in the field for 510K processes. I had the opportunity to assist in Design Validations with surgeons to verify specific products as well as help develop surgical techniques. I reviewed journal articles and test reports to develop new test protocols. I updated engineering drawings with inspection and tolerance changes to fit the current specifications. I evaluated complaint investigation reports from the field for root cause of failure and observed trends within the complaints on a quarterly basis to determine if DFMEA documents needed updating. I worked on a team to provide FDA support and help fill requests during the time of the audit. I completed risk analysis forms, and a detailed review of the previous design changes to enable CE renewals to be completed.Assistant in a research lab with a primary focus on the development of a new cancer drug and associated techniques.I practiced sterile technique in addition to cell passaging. I formulated an excel spreadsheet to capture and display my results based on the hypoxic cells and living cells. I created a protocol for a novel pancreatic cancer approach comparing several different drug dosages and techniques for a specific cell line.Selected to participate in a two-year program to gain experience in three different areas of quality. Design Quality Engineer: Sports Medicine – Rotation 3 (January 2016 – June 2016) • Designated lead quality engineer for patella-femoral knee system • Responsible for creating and revising inspection and quality criteria • Collaborated with suppliers and manufacturing to ensure manufacturing processes conformed with company Quality Management System on all production parts • Assisted on the FDA Response team to remediate quality controls Operations Quality Engineer: Packaging/Patient Specific Instrumentation – Rotation 2 (May 2015 – December 2015) • Responsible for monitoring all PSI and packaging processes to ensure conformance to company policies and procedures • Completed Installation Qualifications and Test Method Validations on new equipment within the manufacturing cell • Responsible for operator certification/training and process monitoring of non-conformance's in PSI manufacturing cell Post-Market Surveillance/CAPA Quality Engineer: Surgical – Rotation 1 (August 2014 – April 2015) • Responsible for investigation/resolution of product complaints for all Surgical product sold inside/outside the US • Evaluated all CAPA phases while assisting the investigator in determining root cause and ensuring the actions were being correctly implemented • Created and maintained quality documentation for the process of dispositioning returned products for the Post Market Surveillance complaint handling system.

Ally Roettgers

I was an influential part of two remediation teams where I gathered information to help create chang...
Winona Lake, Winona Lake, United States

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Ally Roettgers’s Email ally.roettgers@zimmerbiomet.com

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Ally Roettgers’s Location Winona Lake, Winona Lake, United States

Ally Roettgers’s Current Industry Zimmer Biomet

Ally Roettgers’s Prior Industry Zimmer | University of Louisville

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Work Experience

Zimmer Biomet

Senior Development Engineer

2016-06-01 00:00:00 - Present

Zimmer

Knee Development Co-op

2014-01-01 00:00:00 - 2014-05-01 00:00:00

University of Louisville

Research Assistant

2011-08-01 00:00:00 - 2013-08-01 00:00:00

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FAQ About Ally Roettgers

Ally Roettgers is located at
Winona Lake, Winona Lake, United States

Ally Roettgers is a I was an influential part of two remediation teams where I gathered information to help create change logs, scope documents, and clinical history memos. As part of a quality assurance initiative I helped in the closure of gaps that were found during the process of Design History File remediation. This included compiling sales and complaint data to ensure all risk mitigation's had been addressed and were below a certain occurrence level. I updated DFMEA's of the provisional instruments and the cases used for the launch of a new implant. I also assisted in supporting a new product development launch from the perspective of similar device analysis and meeting current regulatory requirements related to risk management.I managed a Pre-Release Product Review in the final stages of launching to ensure that all specifications and tolerances were met from development to packaging checks. I assisted in the implementation for more efficient processes for Zimmer's packaging plant in Puerto Rico. I managed two of the clean rooms to ensure production was running smoothly and producing the output per hour that we expected. I documented comparative analysis risks to previous medical devices in the field for 510K processes. I had the opportunity to assist in Design Validations with surgeons to verify specific products as well as help develop surgical techniques. I reviewed journal articles and test reports to develop new test protocols. I updated engineering drawings with inspection and tolerance changes to fit the current specifications. I evaluated complaint investigation reports from the field for root cause of failure and observed trends within the complaints on a quarterly basis to determine if DFMEA documents needed updating. I worked on a team to provide FDA support and help fill requests during the time of the audit. I completed risk analysis forms, and a detailed review of the previous design changes to enable CE renewals to be completed.Assistant in a research lab with a primary focus on the development of a new cancer drug and associated techniques.I practiced sterile technique in addition to cell passaging. I formulated an excel spreadsheet to capture and display my results based on the hypoxic cells and living cells. I created a protocol for a novel pancreatic cancer approach comparing several different drug dosages and techniques for a specific cell line.Selected to participate in a two-year program to gain experience in three different areas of quality. Design Quality Engineer: Sports Medicine – Rotation 3 (January 2016 – June 2016) • Designated lead quality engineer for patella-femoral knee system • Responsible for creating and revising inspection and quality criteria • Collaborated with suppliers and manufacturing to ensure manufacturing processes conformed with company Quality Management System on all production parts • Assisted on the FDA Response team to remediate quality controls Operations Quality Engineer: Packaging/Patient Specific Instrumentation – Rotation 2 (May 2015 – December 2015) • Responsible for monitoring all PSI and packaging processes to ensure conformance to company policies and procedures • Completed Installation Qualifications and Test Method Validations on new equipment within the manufacturing cell • Responsible for operator certification/training and process monitoring of non-conformance's in PSI manufacturing cell Post-Market Surveillance/CAPA Quality Engineer: Surgical – Rotation 1 (August 2014 – April 2015) • Responsible for investigation/resolution of product complaints for all Surgical product sold inside/outside the US • Evaluated all CAPA phases while assisting the investigator in determining root cause and ensuring the actions were being correctly implemented • Created and maintained quality documentation for the process of dispositioning returned products for the Post Market Surveillance complaint handling system.