Quality Assurance and Regulatory Assistant

Position Description: The Quality Assurance and Regulatory Assistant has the responsibility for assisting Versah’s Chief Operating Officer in maintaining Versah’s Quality Management System and regulatory compliance for product and process to prescribed standards and regulations.
Qualifications: * Associate or bachelor’s degree.
* 3-5 years of experience in regulatory and quality management, preferably in a medical device manufacturing environment.
* Strong knowledge of ISO 13485, FDA QSRs and other international regulations including Europe preferred.
* Experience with quality and regulatory audits.
* Excellent communication, leadership, and problem-solving skills.
Responsibilities * The Quality assistant will include serving as a secondary Management Representative ensuring Risk Based Quality System requirements are established and effectively maintained and implemented.
* Responsible for conducting annual Management Review Meetings and establishing Quality Plans for organizational changes.
* Assist in scheduling the internal and external quality system audits.
* Execution of licensing and registering products in all markets.
* Direct communication with auditors and regulators specific to requirements.
* Responsible for quality management system documentation and record control.
* Coordinate with Versah’s regulatory consultants to maintain regulatory compliance based on updated and new regulations including communication within the organization.
* Coordinate with Human Resources and management for maintaining training records and requirements.
* Assist in documenting quality issues, non-conformities, and deviations with inputs on resolutions and corrections.
This includes customer complaints and adverse event reporting.
* Assist in the management and execution of the Corrective and Preventive Action System.
* Assist in overseeing production quality requirements including label control, inspections, and final release.
* Responsible for maintaining a compliant system for product risk management including post-production activities and documentation.
* Assist in coordination of Supplier Control processes for products and services.
Benefits * Competitive Salary between $40 and $50 based upon education and level of experience.
* Healthcare Benefits * 401(k) retirement plan with company contribution * Vacation/Paid Time Off * 9 Paid holidays Job Type: Full-time Pay: $40,000.
00 - $50,000.
00 per year Benefits: * 401(k) * 401(k) matching * Health insurance * Paid time off * Parental leave Experience level: * 3 years * 5 years Schedule: * Monday to Friday Work setting: * In-person * Office Work Location: In person