Amanda Ostrander Email & Phone Number

Mount Juliet, Tennessee, United States

• Directed all aspects of Quality & Regulatory operations for North America including planning, budgeting, staffing, scheduling, monitoring, and reporting.
• Mentored and coached staff members; Providing leadership in times of crisis and change initiatives.
• Global eQMS implementation from design through launch for 18 sites in 12 countries.
• Two facility relocations, integration of three companies (from acquisitions) and two product launches.
• Oversaw complaints and reporting to health authorities; assisted Legal on product liability claims.

Nashville Metropolitan Area

• Consulting services on regulatory and commercialization strategies, product submissions, and quality system development.
• Project management and implementation services as a MasterControl Partner.

Nashville, Tennessee, United States

REGULATORY STRATEGY - Responsible for the development and implementation of US, EU and China regulatory strategic and tactical planning for on market products and those in development. - Drafted submissions for regulatory agencies, CAP accreditation packages, NYSDOH submissions and assisted with reimbursement dossiers for CMS/MolDx. - Company.

Irvine, California & Nashville, TN, United States

LEADERSHIP - Worked on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business and regulatory trends. - Exercised judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions. - Managed and coordinated the.

Irvine, California

QUALITY ASSURANCE - Developed and enhanced the Quality Management System to ensure audit-readiness for US and EU Laboratories. - Oversaw customer complaint determinations, complaint investigations, complaint closures and trend monitoring. - Managed laboratory inspections by state, federal and international agencies (Health Authorities, Notified Body, CAP.

Irvine, CA

COMPLIANCE - Ownership of Internal Audits, Management Review, Site Metrics and associated programs. - Assist in management of Non-Conformance/CAPA, Training, and Trending activities. - Participate in external (Health Authority, Notified Body, FDA) and internal audits. - Work with Global Quality System communities to lead improvement and compliance.

Cardiff-by-the-Sea

SOLUTION ARCHITECTURE - Designed solutions for standard practices/ regulatory requirements for automotive, life science and technology companies. - Developed quality system programs with associated metrics to identify positive and negative trends for Product Lifecycle Management, Document Change Control, Training, Supplier Management, Inspection.

Aliso Viejo, California, United States

DOCUMENT CONTROL - Oversaw engineering change order process (ECO, CR, CCB) – ensured all required signatories were accounted for, change requests were processed in a timely manner, released documents and parts, maintained bill of materials and routers. - Maintenance of Standard database (ISO, CFR, ANSI, etc.) and Device Master Record documents. - Led.

Costa Mesa, CA

ADMINISTRATIVE - Maintained Vendor and Member information in Microsoft Dynamics (CRM). - Organized and maintained hard-copy files. - Sorted large quantities of incoming and outgoing mail. - Various other organizational projects.

Laguna Hills, California

MANAGEMENT - Attended conferences with account executives and coordinators. - Trained and mentored fellow managers. - Maintained schedule to meet customer sales demands. - Maintained Year over Year Growth despite challenging economic environment. - Conducted Inventory demand planning. SALES / CUSTOMER SERVICE - Maintaining customer relationships and.

Laguna Hills, California

Bachelor'S Degree, Psychology

Associate'S Degree, Psychology

Cosmetology License, Cosmetology/Cosmetologist, General