Eng, Computer Systems at Vontive

Tijuana, Baja California, Mexico

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, BiotechnologyIndustries

Requirements

Bachelor's degree in Industrial Chemistry, Chemical Engineering, Industrial Engineering, or similar disciplines
2-3 years of experience in validations, qualification of manufacturing equipment, and critical systems
2-3 years of minimum experience in process validation, analytical methods validation, and computerized systems validation
2-3 years of minimum experience in quality assurance processes, execution of audits, and application of manufacturing processes
Advanced English proficiency
Knowledge of computer systems, statistics, equipment qualification
Knowledge of computerized systems and process validation, environmental control, and application of local and international regulations to document control and audits
Knowledge of basic statistics, Six Sigma methodology, and risk assessment handling

Responsibilities

Monitor compliance with FDA regulations for export countries, international standards (ISO 9001/ISO 13485), and corporate requirements, with special attention to 21CFR 820.22, 30, 65, 70, 75, 90, 100, 130, 184, and 198
Perform statistical analysis of process variation, process/product control, risk analysis of plant product families, and implement improvement actions resulting from internal and external product experience data analysis
Ensure compliance with applicable regulations to maintain validation status
Perform qualification and validation process activities
Qualify critical equipment and systems used in manufacturing processes
Comply with the current Master Validation Plan
Review validation protocols and reports
Collect information attached to validation protocols
Prepare and keep updated procedures applicable to qualification and validation processes according to corporate standards and national/international legislation
Participate in the decision-making structure concerning regulatory compliance and quality standards in all described operations
Provide direct support in regulatory inspections
Apply and follow EHS guidelines according to established procedures, standards, and official Mexican norms
Support Quality System compliance by participating in investigations as owner, ensuring NCR/CAPA follow-up activities are executed, completed, and documented correctly
As a quality approver, ensure investigations have adequate root cause analysis and that investigation closures or actions are executed correctly, meet system requirements, and are properly documented

Skills

Key technologies and capabilities for this role

FDA Regulations21CFR 820ISO 9001ISO 13485Statistical AnalysisProcess ControlRisk AnalysisProcess ValidationEquipment QualificationValidation Protocols

Questions & Answers

Common questions about this position

What is the employment type for this position?

The position is full-time employment.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What key skills or responsibilities are required for this role?

The role requires expertise in FDA regulations (21CFR 820 sections), statistical process analysis, risk analysis, validation and qualification of equipment/systems, and ensuring compliance with ISO 9001/ISO 13485 standards.

What is the company culture like at Vantive?

Vantive fosters a community of focused, courageous people who don't settle for mediocrity and are driven to improve patients' lives worldwide through innovation in vital organ therapies.

What makes a strong candidate for this Engineer, Computer Systems role?

Strong candidates will have deep knowledge of FDA regulations, ISO standards, statistical process control, validation processes, and experience supporting regulatory inspections and quality investigations.

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.

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