Nventric, Inc. · 1 week ago
Quality Assurance Associate
Arcadia, CA
Full-time
Onsite
New Grad, Entry Level
$24/hr - $30/hrNventric, Inc. is a company focused on maintaining high-quality standards in the medical device industry. They are seeking a Quality Assurance Associate to support the Quality System maintenance and assist with various QA/QE tasks to ensure compliance with international Quality System requirements.
Medical DeviceProduct DesignTest and Measurement
Responsibilities
Support development and implementation of Nventric’s quality policies and practices
Support maintenance of Quality Management System in full compliance with ISO 13485 and FDA QSR
Support in document design reviews, training plans, internal/external audits, etc., as necessary
Ensure design documentation aligns with regulatory compliance requirements
Perform inspection activities from filling out forms, inspecting components based on technical drawings, to recording data
Support Inspections regarding Receiving, In-Process Quality Control, Finished Goods Quality Control, and other material inspections as necessary
Support the traceability and inventory tracking of materials transferred from Manufacturing / QC Inspections to Inventory
Support regulatory compliance and quality plans and strategies in concert with affected functional areas
Support Quality activities related to maintaining DCO and inspection of goods
Monitor FDA and other agency laws and regulations, and provide regulatory interpretation and impact analysis on company projects
Review product development and clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance
This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale
Coordinate and prepare, or support the preparation of regulatory submissions, including documentation required for registration of products in the markets to which Nventric distributes their devices
Proactively champion quality issues where applicable in company-wide activities
Collaborate with R&D to determine the quality assurance strategy from product inception to product launch
Support Supplier QA, Manufacturing QA, and Design Assurance, as necessary per QA/QE
Other duties as assigned
Qualification
Required
Bachelor's degree or equivalent, relevant professional experience in a regulated industry preferred (medical device experience preferred)
Excellent interpersonal, organizational, and communication skills
Excellent analytical and problem solving skills
High attention to detail and accuracy
Ability to recognize problems and take corrective measures
A team player who is open to wearing many hats and willing to jump in when needed
Diversity and flexibility to support Nventric's goals in collaboration with different disciplines
Computer literate including word processing, spreadsheets, database, presentation, graphics
Preferred
Early and late stage development experience is a plus
Benefits
Health insurance
Dental insurance
Vision insurance
Sick time off
Employee assistance program
Flexible spending account
Health savings account
Life insurance
401(k)- after 90 days
Company
Nventric, Inc.
We specialize in medical device development for electrophysiology, neurovascular, coronary, peripheral, and arterial applications.
Founded in 2019
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$10.55M2024-02-06Series B· $10.55M
2019-05-01Pre Seed
2019-05-01Non Equity Assistance
Leadership Team
Sungwoo Min
CEO
Recent News
2023-06-07
2023-05-05
Company data provided by crunchbase