Documentation Contractor, Support
Blackbird LabsSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Healthcare, BiotechnologyIndustries
Requirements
- Knowledge of FDA regulations for export countries, ISO 13485 international standards, and corporate requirements
- Understanding of risk administration processes related to document control and handling in the Quality Management System (SGC)
- Familiarity with Good Documentation Practices (GDPs) for participation in related activities and training
- Proficiency in ERP systems for managing part numbers, BOMs, and routes at the Tijuana site
Responsibilities
- Monitors compliance with FDA regulations, ISO 13485 standards, corporate requirements, and risk administration for document control in the SGC
- Administers System of Records (SoR) activities, ensuring effective management of document issuance, updates, obsolescence, and withdrawal, while detecting deviations preventively
- Monitors processing and follow-up to ensure periodic review updates for active documents in each area
- Executes activities for entering, modifying, and obsoleting part numbers, BOMs, and routes in the Tijuana site's ERPs
- Analyzes and tracks weekly metrics for logistics, on-time compliance, and change control per document
- Participates in activities and training related to Good Documentation Practices (GDPs)
- Digitizes, controls, maintains, and safeguards electronic and physical files (DHRs, validation protocols, and applicable regulatory documents), ensuring correct retention periods per SGC policies
- Distributes controlled copies of master documents to departments and maintains distribution records
- Purchases required supplies for the documentation area and handles supplier payments
- Supports Quality System compliance by participating in additional activities requested by the immediate supervisor, such as NCR/CAPA follow-up investigations and internal/external SGC audits
Skills
FDA Regulations
ISO 13485
Document Control
Quality Management System
Risk Management
Records Management
Process Monitoring
Vontive
Provides investment property mortgage solutions
About Vontive
Vontive provides investment property mortgages using technology to simplify and speed up the loan process. Their main product is a "bolt-on" technology that allows retail brands to easily launch their own mortgage services without needing programming skills. This no-code solution can be set up in just a few weeks, making it quicker for brands to offer mortgages. Vontive stands out from competitors by acting as a bridge between real estate investors, lenders, and capital providers, charging fees for their services that reduce traditional risks and inefficiencies in real estate financing. The company's goal is to modernize the investment real estate market by making the mortgage process more efficient and transparent for both retail brands and financial institutions.
San Francisco, CaliforniaHeadquarters
2017Year Founded
$32.1MTotal Funding
DEBTCompany Stage
Financial Services, Real EstateIndustries
11-50Employees