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Ann L.
Privacy and Continuous Monitoring Branch Chief
United States
Details
Education:
Bachelor of Engineering
Physics
Carl von Ossietzky Universität Oldenburg
2012 : 2016
Master of Arts - MA
National Security and Strategic Studies
U.S. Naval War College
2022 : 2026
Master of Arts - MA
Negotiation, Conflict Resolution, Peace building
California State University-Dominguez Hills
2017 : 2019
Physics
Carl von Ossietzky Universität Oldenburg
2012 : 2016
Master of Arts - MA
National Security and Strategic Studies
U.S. Naval War College
2022 : 2026
Master of Arts - MA
Negotiation, Conflict Resolution, Peace building
California State University-Dominguez Hills
2017 : 2019
Experience:
2021 : Present
USPTO
Supervisor IT Cybersecurity Specialist
● Ensure Medical Software/Medical Devices are ready compliant for release in EMEA.
● Manage the quality life cycle of all software related to the QMS
● Ensure compliance with ISO 13485 : 2016
● Responsible for Customer Complaints and CAPA Investigations
● Act as Compliance Manager for The General Data Protection Regulation (GDPR)
● Lead a cross departmental team to implement various Company Policies
● Participation in Supplier, Internal, and governmental Audits
2019 : 2021
Omron Healthcare
QA/RA engineer
● Maintain the quality life cycle of all software related to the QMS
● Evaluate and if necessary conduct testing for software related to the QMS
● Maintenance and improvement of QMS with ISO 13485 : 2016
● Act as Compliance Manager for The General Data Protection Regulation
● Participation in Supplier, Internal, and governmental Audits
2017 : 2019
Omron Healthcare Europe
Jr. QA/RA Engineer
I am part of the U.S. delegation to the Y7 Summit 2018 in Ottawa, Canada. Y7 is a formal part of the Canadian G7 presidency 2018. Young professionals discussed the pertinent issues of Climate Change and Environment, the Future of Work and Gender Equality. We had the great opportunity of meeting with the G7 serpa teams to discuss our these issues and how the Y7 delegations approached them. We negotiated a Call to Action that was presented to the G7 leaders at the G7 Summit 2018 in Charlevoix, Canada.
2018 : 2018
Y7-Summit 2018
US Delegate to the Y7-Summit 2018
objective is to safeguard the application of proper methods and tools to ensure products and services meet or exceed MTEE, customer, and legal requirements.
Tasks :
- Reporting APQP status
- Technical reviews
- Validating PPAPs, manufacturing process
- Implementing Project Quality Plan
- Conduct Internal and external audits Process audit, PSO
- Initiate, complete 8D investigation, reporting, and follow-up
- Ensuring compliance with quality, safety, environment OSH regulations and procedures
2016 : 2017
Mitsubishi Turbocharger and Engine Europe B.V.
Jr. Project Quality Engineer
USPTO
Supervisor IT Cybersecurity Specialist
● Ensure Medical Software/Medical Devices are ready compliant for release in EMEA.
● Manage the quality life cycle of all software related to the QMS
● Ensure compliance with ISO 13485 : 2016
● Responsible for Customer Complaints and CAPA Investigations
● Act as Compliance Manager for The General Data Protection Regulation (GDPR)
● Lead a cross departmental team to implement various Company Policies
● Participation in Supplier, Internal, and governmental Audits
2019 : 2021
Omron Healthcare
QA/RA engineer
● Maintain the quality life cycle of all software related to the QMS
● Evaluate and if necessary conduct testing for software related to the QMS
● Maintenance and improvement of QMS with ISO 13485 : 2016
● Act as Compliance Manager for The General Data Protection Regulation
● Participation in Supplier, Internal, and governmental Audits
2017 : 2019
Omron Healthcare Europe
Jr. QA/RA Engineer
I am part of the U.S. delegation to the Y7 Summit 2018 in Ottawa, Canada. Y7 is a formal part of the Canadian G7 presidency 2018. Young professionals discussed the pertinent issues of Climate Change and Environment, the Future of Work and Gender Equality. We had the great opportunity of meeting with the G7 serpa teams to discuss our these issues and how the Y7 delegations approached them. We negotiated a Call to Action that was presented to the G7 leaders at the G7 Summit 2018 in Charlevoix, Canada.
2018 : 2018
Y7-Summit 2018
US Delegate to the Y7-Summit 2018
objective is to safeguard the application of proper methods and tools to ensure products and services meet or exceed MTEE, customer, and legal requirements.
Tasks :
- Reporting APQP status
- Technical reviews
- Validating PPAPs, manufacturing process
- Implementing Project Quality Plan
- Conduct Internal and external audits Process audit, PSO
- Initiate, complete 8D investigation, reporting, and follow-up
- Ensuring compliance with quality, safety, environment OSH regulations and procedures
2016 : 2017
Mitsubishi Turbocharger and Engine Europe B.V.
Jr. Project Quality Engineer
Company:
USPTO
Years of Experience:
7
Spoken Language:
Dutch, English, German
Skills
Analytical Skills, Big Data, Business Intelligence (BI), Business Strategy, C++, Customer Service, ISO/TS 16949, ISO 13485, Leadership, Mediation, Medical Devices, Microsoft Excel, Microsoft Office, Microsoft Word, Negotiation, Office 365, Outlook, PowerPoint, Professional Ethics, Public Speaking, Quality System, Regulatory Affairs, Six Sigma, Tutoring, Windows
About
Positive leader that utilizes lean methods to increase productivity.
Uses knowledge gained from others and research to enhance and develop policies to solve problems and improve everyday life.
Profile Photo
