Senior Manager - QA at Vontive

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, Kidney CareIndustries

Requirements

Demonstrated compliance knowledge in medical device and drug product development, change control, CAPA, and risk management
Strong verbal and written communication skills
Strong interpersonal/communication/influencing/negotiation skills
Demonstrated leadership, teaming, and communication skills accomplishing success with large teams
Demonstrated business acumen: international experience
Knowledge of FDA (21 CFR Part 210, 211, 820, 803, 806), ISO 13485, ISO 14971, IEC 60601, ICH, EMEA, and CFDA regulations and standards for medical devices and therapeutics
Strong analytical and problem-solving skills utilizing DMAIC tools; Six Sigma Engineering, ASQ or other certifications desirable
BS Degree (engineering, science or pharmaceutical related discipline) with 15+ years of experience in medical device industry or MS Degree with 5 years of experience in medical device industry
5-7 years of leadership experience
Prior engineering/quality engineering or project management experience with a pharmaceutical product and medical device product
Demonstrated skill of managing larger team supporting new product initiative and sustenance project with good understanding of medical device lab environment

Responsibilities

Overall responsibility for maintaining site compliance with the requirements of the Baxter Quality Management System (QMS)
Assure excellence in site implementation of the product development process
Responsible for on-site training on product development, change control, nonconformance/CAPA processes, and design best practices
Establishing and maintaining site QMS certifications, as applicable
Responsible for building and developing a quality team that are experts in design assurance practices and actively partner with R&D teams to assure a high quality product
Collaborate with teams to provide strategy and guidance for meeting Baxter requirements and External Quality Standards as appropriate
Organize and implement site support of Corporate audits and Notified Body regulatory inspections
Participate in scheduled MRs; approve and distribute (or assign a designee to distribute) Management Review minutes
Ensure the Operational Structure’s quality system requirements and GxP compliance status are established and effectively maintained per the applicable regulations
Report on the performance of the Operational Structure’s quality system to QMR for review and escalates as needed

Skills

Quality Management System

QMS

Product Development Process

Change Control

Nonconformance

CAPA

Design Assurance

Design Best Practices

Regulatory Compliance

Audits

Management Review

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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