⬧ Administered RFIs and Submittals, increasing project efficiency.⬧ Leveraged BlueBeam expertise to catalog design changes across multiple project phases, improving traceability and version control for complex initiatives across multi-billion-dollar projects.⬧ Rapidly acquired proficiency in Autodesk, Procore, and Bluebeam, demonstrating adaptability and commitment to continuous learning.⬧ Meticulously organized and cataloged design drawing sets, ensuring accurate documentation and easy retrieval for stakeholders throughout project lifecycles.⬧ Fostered effective communication among project teams by promptly notifying stakeholders of document updates and changes, facilitating seamless collaboration.⬧ Optimized design set organization, significantly improving accessibility and cost-effectiveness for stakeholders throughout project lifecycles.

• Policy Exception(s) management as part of the GRC (Governance, Risk & Compliance) program• Third party Vendor management as part of the GRC program. • Internal Phishing program• Internal Audits as both prep for third parties and notified bodies and in response to regulatory bodies auditing the company.• External audits of vendors.• Wrote the Information Security Articles for the monthly company newsletter.

• Represent QA on project related activities.• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. • Organize and deliver training to other departments concerning the activities of Quality services, results of activities, quality initiatives, GDP/GMP etc.• Serve as Regional or Global QA Liaison for assigned customers, vendors and/or functional areas.• Provide regular feedback to Quality Management, on the above activities.• Provide interpretation and consultation to teams on regulations, guidelines, compliance status, and policies and procedures.• provide recommendations to management for continuous process improvements.• Act as line manager for one or more QA staff.• Implemented and maintained the safety & security requirements, improvements and training for the site.

SME: MARS-e, NIST, HIPPA, PUB 1075, ISO 9001 ISO 45001• Plan, conduct, and report audits of processes, systems, projects and/or sites • Oversee and host inspections and audits by clients and regulatory agencies.• Prepare, review and document corrective action plans.• Ensure implementation of Corporate Policies.• Act as a resource on all aspects of GxP and related guidelines and regulations.• Oversee and participate in the documentation, reporting, and closure of compliance issues.• Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.• Maintain a knowledge of current GMP/GDP regulations, guidelines, and related auditing techniques appropriate to work responsibilities.• Promote the concept of quality, the principles of quality management, devise, and implement quality improvements.• Evaluate policies and procedures for compliance with applicable regulations/guidelines and

Supported engineering team by overseeing document control processes.Controlled engineering drawings and reproductions, project reports, specifications, product proposals, and related documentation. Managed implementation and maintenance of Engineering Change Notice System, used for product development, repair, and improvement. Maintained consistent compliance of documentation procedures with regulatory requirements. Ensured that all changes to engineering draws were documented for audit purposes. Managed six projects in a one-year time frame, finishing six weeks before the deadline.

* Process documentation changes in Agile: Ensure electronic capture and retrieval of quality documents and records by reviewing, evaluating and processing changes accurately and in a timely manner while ensuring that they meet the department and organizational goals and objectives. * Specialized on the devices and software systems of the company products. Knowledge and upkeep of the Design History files from initialization of the design, validations and testing, to the implementation of sustaining manufacturing.* Experience with and, clear understanding of the Quality System Regulations (QSR) and ISO 13485 requirements, and other notified bodies in accordance with medical device manufacturing. * Provide guidance and communication to engineers in order to share best practices and resolve change issues and/or discrepancies and promptly respond to questions and issues raised by Originators and Approvers.

As a temporary employee for Nelson I had the opportunity to work at several places using and learning a multitude of new skills. Additionally, I was able to improve other skills. My placement opportunities in addition to Volcano were AT&T Broadband: Data Entry Clerk. Entered data from repairs into a database. (6 weeks)ACCO: Receptionist Answered phones, mail, and back office duties ( 3 ½ months)Fleetwood Homes: Admin Assistant. All back office duties as well as Escrow, Customer Service, Vendor set-ups, Accounts payable and Accounts Receivable. (8 month assignment)Morrision Homes: Receptionist (2 month)Ralph’s Supermarket: Receptionist (4 month)Triad Family: Receptionist: Answered a multiple phone line and scheduled visits with parents and foster families. (2 month)Valentine Construction Office Manager. I was hired and worked a year but the company dissolved.