Vanity Studios is a makeup and photography studio located in Maumee, OH. One half specializes in beauty, high fashion and special FX makeup. The other half offers creative portraiture and branding photography.

Planned, coordinated, directed, and oversaw all quality system activities, driving continuous improvement and operational excellence.Directed and maintained a robust internal audit program, identifying areas for improvement and ensuring compliance with regulatory requirements.Implemented corrective and preventive actions to address nonconformances, customer complaints, and deviations, enhancing product quality and customer satisfaction.Managed and executed comprehensive safety programs and mitigated workplace hazards. Coordinated and conducted safety training programs, ensuring all employees are informed and compliant with safety regulations and best practices.Conducted management reviews, collecting and analyzing key performance indicators and organizational metrics to drive informed decision-making and continuous improvement initiatives.Served as Management representative and the key contact for ISO and OSHA, ensuring all regulatory requirements are met and maintaining open communication with relevant authorities.

Responsible for planning, coordinating, directing and overseeing all quality activities.Accountable for the overall creation, direction, performance and management of the QMS.Investigate, write and/or approve all quality exception reports including nonconformance reports (NCRs), supplier corrective action requests (SCARs), customer complaints, corrective/preventative actions (CAPAs), risk assessments and deviations.Providing regulatory input and developing strategies for the effective management and continuous improvement of manufacturing programs and quality processesMaintaining the internal audit system; creating the schedule, performing ISO (9001 and 13485) audits and completing corrective/preventive actions.Creating and conducting management reviews including data and trend analysis.

True Label develops and manufactures labels used in the chemical, pharmaceutical and medical device industries.

Created the company’s first Quality Management System. Accountable for building a completely new quality program utilizing ISO 9001:2015 and directing all Quality activities.Developed, implemented and managed 8D Corrective Action Request (CAR) & Supplier Corrective Action Request (SCAR) programs.Coordinated all containment and corrective action processes for nonconforming product at 7 separate facilities.Established inspection procedures, sampling test methods and product quality assurance for raw materials, in-process parts and finished products.Led cross-functional KPI scorecard review and data analysis.Implemented a supplier quality manual and supplier scorecard program and developed a process for calculating the monthly cost of quality.Developed, implemented and audited the health and safety programs in accordance to OSHA 1910.

Ball Multimedia specialized in event photography and videography.

Responsible for managing, hosting and executing the external audit program which includes audits and investigations from the FDA, BSI, TUV, Corporate and third party Auditors Responsible for redeveloping, sustaining, managing and executing the internal audit program Planning, executing and managing internal Quality Audits to ensure compliance with 21 CFR 803, 21 CFR 804, 21 CFR 806, 21 CFR 820, ISO 9001, ISO 13485 and RDC-16Leading, coordinating, training and supervising a team of Quality Auditors with 3 direct reportsExtensive involvement with FDA consent decree remediation activities

Performing all activities associated with Corrective and Preventive Actions (CAPAs); which includes drafting problem descriptions, containment actions, investigations, corrective-preventive actions, effectiveness check plans and final effectiveness check reportsLeading cross-functional root cause investigation activities utilizing appropriate tools such as 5 Whys, cause-and-effect (fishbone) diagrams, process mapping and fault tree analysisPresenting and addressing questioning on CAPA progression to the CAPA Review Board (CRB)

Assisting in the re-design of a Document Control system that utilizes both Change Management and Records Management Leading cross-functional teams in the development of design failure mode effects analyses (DFMEAs); facilitating meetings, providing input, drafting final reports and tracking approvals

Responsible for overseeing the Quality Systems Documentation departments in four manufacturing facilities; providing supervision, support and direction within those departmentsLead Auditor; maintaining the internal quality auditing system, facilitating and executing audits based on internal procedures, 21 CFR part 820, Health Canada GMP Guidelines, and ISO 13485Regional administrator of the WindChill document control software system for five separate facility libraries; assisted with the design, development and validation of the system

Maintained and orchestrated the internal quality auditing system, facilitating and executing audits based on internal procedures, 21 CFR part 820, Health Canada and Food Branch Inspectorate GMP Guidelines, and ISO 13485Developed and maintained document control systems in accordance with 21 CFR part 820Administrator for revising and updating controlled documentation via an electronic engineering change order (ECO) system

Responsible for mixing dry chemicals to a set concentration and then running them through a manufacturing process in order to produce a concentrated product used in dialysis treatmentsResponsible for documenting the manufacturing process via device history records