Roshana Joshi
Medical Device Quality Inspector | GMP & QSR Compliance | 3+ Years GxP
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About
Quality professional with 3+ years in medical device inspection, GMP/QSR compliance, and GxP environments. Skilled in process validation, documentation control, and continuous improvement across pharmaceutical and medical device industries.
Experience
PB II, Medical device Quality Inspector - Penumbra
(2021-01 - 2025-12)
Recently working in Penumbra as PB II, done by Quality Lead training and Medical device Quality Inspector in CER 1 Catheter coils. Responsible for inspecting components and products to ensure they meet quality standards and regulatory requirements as well follow the procedures. They support daily inspection activities, apply Good manufacturing Practice (GMP) and Quality system Requirements (QSR), and adhere to the company's Quality Management System (QMS).
Quality policy, LCD, Internal audit and External Audit. Attending monthly QC meeting.
- Executed routine inspections and functional tests on components and finished medical devices to ensure QSR/GMP compliance
- Maintained accurate inspection records and SOPs, ensuring full traceability and audit-readiness across all documentation
- Supported continuous improvement initiatives, driving process consistency and reducing non-conformance occurrences
Quality Assurance - Blue Apron LLC. - Richmond, CA
(2016-04 - 2020-05)
Routine product testing. Temperature monitoring, following quality standards and utilizing best practices with FDA.
- Delivered quality assurance oversight for food production operations, ensuring adherence to regulatory and safety standards
Billing and Financial Operations - Professional Experience
(2010-01)
Over 15 years of experience in billing transactions and financial operations within the housing and construction sector. Skilled in managing invoicing, payment processing, account reconciliation, and customer billing systems. Additionally experienced in network-based business operations, including business development, client relationship management, and coordination of network services and projects.
- Managed billing operations including invoicing, payment processing, and account reconciliation across multiple client accounts
Education
Master's degree - Operation Management - NCC Tribhuvan University (2013-01 - 2013-12)
Vocational course - Accounting Receivable specialist - Berkeley Adult School (2019-01 - 2019-12)
