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Sarah Moss is a Project Engineer at Prime Path Medtech™. She possess expertise in business consulting, manufacturing engineering, root cause analysis, 21 cfr 820, failure mode and effects analysis and 20 more skills.
Prime Path Medtech™
View- Website:
- primepathmedtech.com
- Employees:
- 12
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Project EngineerPrime Path Medtech™Houston, Tx, Us
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Client LeadPrime Path Medtech™ Mar 2020 - PresentMinneapolis, Minnesota, UsManage Quality, Regulatory, and Clinical Projects• Clinical Project Support: Clinical trial site management, protocol generation, IRB communication, study budgets, contract negotiations, and case report form development• Quality Project Support: Manufacturing validations, SOP/Work Instruction development, Corrective and Preventive Actions, Supplier Management, Auditing, ISO 13485 implementation• Regulatory Project Support: Adverse event review, Letters to file, 510(k) submissions, Investigational Device Exemptions• Design Control Management: Project scheduling, resource management, functional testing, and product specification development
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ConsultantMasterthink Feb 2008 - Mar 2020• Perform root cause analysis for clients regarding project failures and financial losses• Consult with stakeholders to identify needs, develop policies, and implement processes to improve business management and performance• Develop reports to trend financial, manufacturing and construction related data using various software (Tableau, Microsoft Power BI, Excel) to improve company performance• Advise companies on what to measure, how to capture data and how to display the data for meaningful management review• Create customized dashboards, using Tableau and Microsoft BI, to provide interactive reports that assisted with analyzing data and making business decisions
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Process/Product Quality EngineerAlcon Laboratories, Inc. Jun 2001 - Dec 2007Geneva, Switzerland, Ch• Managed and validated the CAPA software implementation in the Houston facility• Performed root cause analysis for returned products associated with customer complaints• Wrote final investigation summaries for complaints, MDRs and vigilance reports• Initiated corrective and preventive action activities for manufacturing related quality issues arising from quality system review and customer complaints•Led the quality engineering department in monthly complaint trend review meetings and tracked action items• Provided trend analysis for CAPA system issues for Management Review• Reviewed malfunction complaint coding and summaries prior to closure• Wrote validation documents and validated production equipment for packaging and boxing of custom surgical packs
Sarah Moss Skills
Sarah Moss Education Details
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Texas A&M UniversityBiomedical Engineering
Frequently Asked Questions about Sarah Moss
What company does Sarah Moss work for?
Sarah Moss works for Prime Path Medtech™
What is Sarah Moss's role at the current company?
Sarah Moss's current role is Project Engineer.
What is Sarah Moss's email address?
Sarah Moss's email address is sa****@****bal.net
What schools did Sarah Moss attend?
Sarah Moss attended Texas A&m University.
What skills is Sarah Moss known for?
Sarah Moss has skills like Business Consulting, Manufacturing Engineering, Root Cause Analysis, 21 Cfr 820, Failure Mode And Effects Analysis, Data Analysis, Product Complaints, Tableau, Engineering, 21 Cfr 803, Strategy, Quality System.
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