Software Validation Engineer at Vontive

Tijuana, Baja California, Mexico

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, Kidney CareIndustries

Requirements

Knowledge of data integrity and computerized systems validation regulations (CFR 21 part 11, Annex 11 of EC, ISO-13485)
Ability to act as SME in data integrity and computerized systems validation
Capability to generate computerized systems validations including applications, Cloud Systems, ERP, production equipment controllers, laboratory equipment, etc
Skills to elaborate validation protocols and reports
Compliance with the current Computerized Systems Validation Master Plan
Ability to collaborate with area and system owners, as well as IT, to ensure corporate strategy compliance for data handling and regulatory compliance in data integrity
Experience in executing follow-up audits for electronic records handling and reviewing maintenance of validated state of computerized systems
Proficiency in following up on remediation plans and risk mitigation actions for data in computerized systems
Technical support skills for users and system owners in design, maintenance, electronic and electrical features, and security elements for plant computerized systems
Participation in decision-making structure concerning regulatory compliance and quality standards
Ability to develop, modify, and maintain Standard Operating Procedures (SOPs) in the area
Support for additional activities required by supervisor in the quality validations department, complying with established trainings
Participation in employee training for activities that help maintain, develop, and improve the data integrity program

Responsibilities

Monitor compliance with data integrity and computerized systems validation regulatory requirements (CFR 21 part 11, Annex 11 of EC, ISO-13485)
Act as part of the local data governance team and SME regarding data integrity and computerized systems validation
Generate computerized systems validations including applications, Cloud Systems, ERP, production equipment controllers, laboratory equipment, among others
Elaborate corresponding validation protocols and reports
Ensure compliance with the current Computerized Systems Validation Master Plan
Collaborate with area and system owners, as well as IT, to ensure compliance with the corporate strategy for data handling and regulatory compliance in data integrity
Execute follow-up audits for electronic records handling and review maintenance of the validated state of computerized systems
Follow up on remediation plans and risk mitigation actions for data in computerized systems
Provide technical support to users and system owners for design, maintenance, electronic and electrical features, and security elements for plant computerized systems
Form part of the decision-making structure concerning regulatory compliance and quality standards in all described operations
Develop, modify, and maintain Standard Operating Procedures (SOPs) of the area
Provide support in additional activities required by supervisor as part of the quality validations department, complying with previously established trainings
Participate in company employee training for executing activities that help maintain, develop, and improve the data integrity program

Skills

Computerized Systems Validation

Data Integrity

21 CFR Part 11

Annex 11

ISO 13485

Quality Engineering

Remediation Plans

Change Control

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

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Parental Leave

Short- and Long-term Disability Coverage

Life Insurance

Wellness Program

Risks

Increased competition from fintech companies could erode Vontive's market share.

Potential regulatory scrutiny may lead to higher compliance costs and challenges.

Economic downturns could impact demand for investment property mortgages.

Differentiation

Vontive offers a no-code, white-label mortgage solution for real estate investors.

The platform integrates financial institutions through a unique debt marketplace.

Founded by industry veterans, Vontive leverages decades of mortgage and financial expertise.

Upsides

Vontive ranked #10 on the 2022 Deloitte Technology Fast 500 with 9,154% growth.

The company has financed over $1.1 billion in residential properties since April 2022.

Vontive's B2C ecosystem reaches over 1.5 million real estate investors.

Land your dream remote job 3x faster with AI

Try Jobo Free