Lori A. Lapointe Email & Phone Number

Greenville, South Carolina, United States

Greenville, South Carolina Area

Assist with planning & execution of internal audits for compliance with multiple regulations & standards, including FDA, GAMP 5, ISO 9001, ISO 13485, ISO 27001, HIPAA, PCI, ITAR and others as required.Assist customers with FDA validation letters, answering questionnaires and hosting on site audits.Support IT and SaaS teams by providing guidance and training on information security in a regulated environment.Perform risk assessments and assist with the selection of appropriate policies, procedures and controls to mitigate identified risks.Create or revise policies and procedures to ensure continual improvement of the Infor quality management system.

Greenville, South Carolina Area

*Implemented training, tools, and techniques to enable others to achieve quality.*Led staff to plan, formulate and adhere to comprehensive quality procedures.*Ensured the products of our organization provides meets both the internal and external requirements, including legal, ISO 13485:2003, and 21 CFR Part 820 compliance.I have been with the company (GlucoTec/Glytec) from day one and personally witnessed and contributed to our business growth. The various positions held with the company have taught me many facets of our business and the medical device industry.

Greenville, South Carolina Area

*Established a quality management system and delivered ISO 13485:2003 certification to the company under budget and on time.*Promoted quality achievement and performance throughout the organization.*Identified relevant quality-related training needs and developed and delivered a training program to all personnel.

Greenville, South Carolina Area

*Guided, managed and directed the overall provision of Human Resources services and policies for the company.*Responsible for staffing, employment and compliance to regulatory concerns, employee orientation, policy development and documentation, employee relations, company-wide communication and events, compensation and benefit administration, employee safety, welfare and wellness.*Led the efforts of departmental goals and objectives.*Ensured compliance with OSHA regulations and labor, local and state laws.

Greenville, South Carolina Area

*Attended all sessions of the board and all meetings of the shareholders.*Recorded all votes and the minutes of all proceedings.*Provide notice of all shareholder meetings and special Board of Directors meetings.*Performed other duties as prescribed by the President or the Board of Directors.*Kept in safe custody the seal of the Corporation, and when authorized by the Board of Directors, affixed the seal to any required instrument and attested via signature.*Notary Public

Greenville, South Carolina Area

*Maintained detailed records of all subscription agreements and investor contact information.*Collected, recorded and deposited all funds and issued stock certificates accordingly.*Responsible for contents of safety deposit boxes and storing company documents.*Reviewed & signed all company checks.*Recorded meeting minutes and maintained records for Founders Group.*Organized all aspects of trade shows for Sales Team.