Currently the head of all Regulatory Affairs, Quality, and Customer Service activities. Works with all applicable regulatory bodies to maintain compliance with ISO13485 Standards.• Helped bring the existing QMS system into GMP Compliance and keep it maintained.• Worked with BSI America to get our company ISO13485 certified and compliant. • Created a Design & Risk Management File for a Class 1 Medical device to meet the requirements of ISO 14971:2019• Obtained my CQA certification through ASQ.• Completed Lead Auditor Certification for ISO13485:2016 through BSI• Regulatory certification experience with the KFDA, CE/UKCA Marking• Currently working to prepare the company for MDSAP and MDR Reviews

Brought on as Head of the Quality Assurance Department to streamline existing and out of date procedures, in addition to moving those procedures from SharePoint to an XSOL Knowledge Base System. Works with 1 direct report to conduct internal departmental audits as well as laboratory audits. Maintains compliance with the American Association of Tissue Banks (AATB), which accredits the company.

Oversee and direct 15+ department team members in reviewing and creating transfer-student material based on catalogues from partner universities, colleges, and junior colleges, providing students with a resource to determine their transfer credits. Develop strategic direction of the university’s College Articulation Program, comprised of 500 contracts with 700 institutions by establishing workflow processes. Build relationships with school decision makers, including provosts, presidents, and deans to persuade decision makers to participate in the program. Collaborate with Legal Department in administering the program. Maintain compliance with the Higher Learning Commission (HLC), which accredits the university. Established metrics reporting structure for department, including work completed and employee progress reports.Developed and implemented department’s Key Performance Indicators (KPIs), including file completions, quality control scores, and tasks for use in in employee reviews.Initiated an audit of 500 articulation contracts to ensure complete and accurate information for each contract, a process later required by the HLC for accreditation.Selected to beta test the new SharePoint 2013 transition from SharePoint 2007, identifying key issues with the new site, including its inability to access 5K items, and developing solutions to existing problems, such as resolving the 5K item access issue by linking the new site to an Access database.Applied compliance expertise to ensure program complied with federal and state laws and regulations, including Sarbanes/Oxley, ADA, FERPA, and OSHA.Conducted research on the university’s business courses and programs at the request of VP that led to the development of standardized transfer credit guidelines adopted by the Accreditation Council for Business Schools & Programs in 2012 and still presently used.

Completed multiple internal audits for compliance with the American Disabilities Act and student attendance and employee system access requirements Trained, assigned, scheduled, and guided auditor to satisfy compliance work requirements. Met work standards by following production, productivity, quality, and customer-service standards. Addressed and resolved operational problems while identifying process improvements. Communicated audit progress and findings to senior leaders.Created Access database with audit results and report to quickly generate for review by divisional Vice President.Served as Database Administrator for Compliance Department investigations. Satisfied cost standards by monitoring expenses and implementing cost-saving actions, reducing the investigations section expenses by about $2K. Thoroughly prepared for audits by researching various material and developing an action plan achieving at least a 90% rate of compliance with federal and state laws and university policies.

Evaluated and processed student applications, residency status, and transcripts for admission, determining admissibility and course equivalencies and evaluating transfer credits. Established students’ qualifications for admission. Developed Excel spreadsheet to accurately and efficiently track weekly production.

Served as senior resource in advising and counseling university students. Interpreted academic regulations, assessed and evaluated students’ academic progress, and assisted students experiencing academic challenges. Advised students on degree requirements. Designated team members tasks and completed monthly team progress reports.Effectively guided, advised, and counseled about 1K students. Selected to take on leadership role, providing mentoring and support for academic counselors; took over management role and responsibilities in absence of manager.

Completed and recorded customer financial transactions, including processing deposits and loan payments, cashing checks, issuing withdrawals, recording deposits, preparing cashier’s checks, traveler’s checks, and savings bonds. Addressed and resolved customer questions or issues. Recommended additional bank products or services as needed and processed all supply orders.Served as branch’s Head Teller in maintaining branch cash volume and assisting high-cash volume customers.Created client tracking database using Access to better assist customers and improve customer service.

Processed customer financial transactions while ensuring federal compliance for all high-cash volume transactions. Assisted customers with opening and closing various accounts from personal to business.Developed a Word and Access database to identify potential clients.