BSA Validation Engineer
San Jose, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
San Jose, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
San Francisco, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
San Francisco, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
Sunnyvale, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
Sunnyvale, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
Hayward, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
Hayward, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
Sonoma, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
Sonoma, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
Fremont, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
Fremont, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
... CSV (Computer System Validation) activities and documentation • Ensure compliance with ALCOA+ data integrity principles and regulatory standards • Assist in validation lifecycle activities ...
... CSV (Computer System Validation) activities and documentation • Ensure compliance with ALCOA+ data integrity principles and regulatory standards • Assist in validation lifecycle activities ...
BSA Validation Engineer
Alameda, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
Alameda, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
San Mateo, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
BSA Validation Engineer
San Mateo, CA · On-site
... Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate ...
Good knowledge and experience of CSV activities but not limited to. * GxP and 21 CFR Part 11 ... Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304.
Good knowledge and experience of CSV activities but not limited to. * GxP and 21 CFR Part 11 ... Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304.
Sr Quality Engineer I
$94K - $127K/yr
... Computer System Validation (CSV), ensuring compliance with regulatory requirements, lifecycle procedures, and Data Integrity expectations.This position supports and leads CSV activities at the El ...
Sr Quality Engineer I
$94K - $127K/yr
... Computer System Validation (CSV), ensuring compliance with regulatory requirements, lifecycle procedures, and Data Integrity expectations.This position supports and leads CSV activities at the El ...
CSV Engineer
Costa Mesa, CA · On-site
$55 - $60/hr
CSV Engineer Costa Mesa, CA or Seattle, WA(On-site) Visa: USC, GC & H4 EAD Key Responsibilities ... Computer system validation methodologies * Familiarity with risk-based validation execution ...
Quick apply
CSV Engineer
Costa Mesa, CA · On-site
$55 - $60/hr
CSV Engineer Costa Mesa, CA or Seattle, WA(On-site) Visa: USC, GC & H4 EAD Key Responsibilities ... Computer system validation methodologies * Familiarity with risk-based validation execution ...
Computer System Validation (CSV) * Validation maintenance packages * System decommissioning documentation * Provide validation expertise during the development or modification of manufacturing ...
New
Quick apply
Computer System Validation (CSV) * Validation maintenance packages * System decommissioning documentation * Provide validation expertise during the development or modification of manufacturing ...
New
Application Developer, Business Systems
Irvine, CA · On-site
$87K - $123K/yr
Ensure work meets the SDLC, computer system validation (CSV), and 21 CFR Part 11 orGxPrequirements appropriate to each system What you'll need (Required): * Bachelor's degree in Computer Science ...
New
Application Developer, Business Systems
Irvine, CA · On-site
$87K - $123K/yr
Ensure work meets the SDLC, computer system validation (CSV), and 21 CFR Part 11 orGxPrequirements appropriate to each system What you'll need (Required): * Bachelor's degree in Computer Science ...
New
Application Developer, Business Systems
Irvine, CA · On-site
$87K - $123K/yr
Ensure work meets the SDLC, computer system validation (CSV), and 21 CFR Part 11 or GxP requirements appropriate to each system What you'll need (Required): * Bachelor's degree in Computer Science ...
Application Developer, Business Systems
Irvine, CA · On-site
$87K - $123K/yr
Ensure work meets the SDLC, computer system validation (CSV), and 21 CFR Part 11 or GxP requirements appropriate to each system What you'll need (Required): * Bachelor's degree in Computer Science ...
IT Portfolio & Project Manager
Concord, CA · Hybrid
$108K - $127K/yr
Computer System Validation (CSV) and Regulatory Compliance * Coordinate and support Computer System Validation (CSV) activities, including validation planning, execution, and documentation, in ...
IT Portfolio & Project Manager
Concord, CA · Hybrid
$108K - $127K/yr
Computer System Validation (CSV) and Regulatory Compliance * Coordinate and support Computer System Validation (CSV) activities, including validation planning, execution, and documentation, in ...
Leader Software Quality V&V CSV/CSA
Lake Forest, CA · On-site
$200 - $240/hr
Define and operationalize STAAR Surgical's Computer Software Assurance (CSA) and Computer System Validation (CSV) strategy. * Drive transition from traditional documentation-heavy validation models ...
New
Leader Software Quality V&V CSV/CSA
Lake Forest, CA · On-site
$200 - $240/hr
Define and operationalize STAAR Surgical's Computer Software Assurance (CSA) and Computer System Validation (CSV) strategy. * Drive transition from traditional documentation-heavy validation models ...
New
SAP CSV Lead
San Francisco, CA · Remote
$40 - $53/hr
Your Role We are seeking an experienced SAP CSV Lead to provide strategic leadership and oversight for Computer System Validation (CSV) and Computer Software Assurance (CSA) activities supporting SAP ...
Quick apply
SAP CSV Lead
San Francisco, CA · Remote
$40 - $53/hr
Your Role We are seeking an experienced SAP CSV Lead to provide strategic leadership and oversight for Computer System Validation (CSV) and Computer Software Assurance (CSA) activities supporting SAP ...
This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. * Leads the effort to manage, and/or maintains ...
This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. * Leads the effort to manage, and/or maintains ...
Define and operationalize STAAR Surgical's Computer Software Assurance (CSA) and Computer System Validation (CSV) strategy. Drive transition from traditional documentation-heavy validation models ...
Define and operationalize STAAR Surgical's Computer Software Assurance (CSA) and Computer System Validation (CSV) strategy. Drive transition from traditional documentation-heavy validation models ...
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Job description
Job Summary
We are seeking an experienced Business Systems Analyst (BSA) that supports regulatory compliance, patient safety, and continuous product improvement through accurate and timely documentation, assessment, investigation, reporting, and resolution of customer complaints. This role will support the Product Surveillance Manager in various post-market product surveillance activities, Quality , Logistics, Receiving team for the return process, Supplier Quality team for the Supplier related process, Quality compliance group for Nonconformance, Standalone and Audit module . The ideal candidate will partner with Quality Compliance, Manufacturing, and IT teams to gather business requirements, implement system enhancements, and ensure compliance with FDA regulations, global health regulatory requirements, and internal quality standards while participating in system validation activities and ensuring all enhancements follow established Computer System Validation (CSV) processes. Coordinate with technical experts to provide additional data and information requested by regulatory agencies and prepare responses to facilitate regulatory approvals. Provide risk-based guidance and regulatory input to projects and issues while ensuring cross-functional alignment and resolution.
Key Responsibilities
- Partner with business stakeholders to elicit, analyze, document, and validate business and system requirements for QMS enhancements and projects.
- Support and administer the Complaint, Return Material Authorization (RMA), and Supplier Quality Management (SQM), Nonconformance, Standalone CAPA modules within the QMS.
- SQL Expertise: Experience with Microsoft SQL Server Management Studio (SSMS). Advanced proficiency in T-SQL, PL/SQL, and SQL Server Management Studio (SSMS).
- AssurX Experience: Hands-on experience configuring Eventhooks, Datalinks and managing the AssurX Quality and Compliance software including Complaints, RMA, Supplier Management and Audit modules.
- Database Architecture: Solid understanding of database design, normalization, indexing, and query optimization.
- Experience with data validation, migration, and reconciliation.
- Data Integrity: Ensure data accuracy, consistency, and HIPAA/FDA compliance (such as 21 CFR Part 11) across all database environments.
- System Integration: Develop and maintain ETL processes and APIs to integrate the AssurX and Trackwise platform with enterprise systems such as ERP, SAP, CRM, or Active Directory.
- Regulatory Knowledge: Familiarity with quality standards and regulatory compliance (e.g., ISO, FDA, GxP).
- Communication: Strong analytical and cross-functional communication skills to translate business requirements into technical database solutions.
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About Truglobal
Sourced by ZipRecruiter
Industry
It services
Company size
201 - 500 Employees
Headquarters location
Santa Clara, CA, US
Year founded
2004