Kevin Guytón Email & Phone Number

Mentor, Ohio, United States

Aurora, Ohio

Corporate Quality Director encompassing all aspect of the business. I have successfully taken an audit score of 40 and improved systems to raise the score to 77 in only weeks and continue to make improvement to achieve an excellent rating. Improved the system with a score of 82 with my recent audit: underlying issues with facilities/equipment. I am in the process of changing the overall culture within the organization that strives of Quality. I have incorporated a change in SOP's to drive not only simplicity but also compliance within the CFR's and cGMP standards. Within Quality improvements, I am able to generate new business up to 10 million in revenue.

Aurora, Ohio

Responsible for securing the trust and confidence of Natural Essential’s customers by consistently providing exceptional quality and service. The Director must be committed to exceeding the objectives of customer and government agencies for product strength, safety, quality, integrity, and purity. Quality Assurance will have the authority to approve, quarantine, or reject all incoming materials, work-in-process, and finished products.Maintaining GMP Compliance at Natural EssentialsEstablishing, approving, and maintaining all written procedures and associated formsReviewing and revising all procedures and forms as necessaryMaintaining an approved supplier listApproving and maintaining all material and product specificationsEvaluating and approving or denying all vendors and suppliers of raw material, packaging, and labelingReviewing all documentation for incoming materials, production processes, material and product testing, and final disposition. Documentation will be reviewed for completeness, accuracy, and conformity to specificationRetaining all product documentation for the defined appropriate amount of timeMaintaining a retained sample depositoryExamining and/or testing all incoming materials, work-in-process, and finished products for conformity to specificationsConducting in-house auditsReceiving, investigating, and answering customer complaintsCreating Certificates of Analysis and/or Compliance as necessaryProviding GMP compliance training for employeesProviding guidance and leadership for Quality Assurance and Quality Control

Ohio, United States

Aurora, Ohio

Management of product development, manufacturing, and processing of a variety of OTC, natural ingredients and essential oils.

Cleveland, Ohio Area

Ran ERB (Event Review Board) meeting for all event requests throughout company to ensure product safety.• Correlated risk, harms with noted failure modes for medical devices led to continuity across product lines.• Led Event Review Board for requests concerning deaths, non-conforming products, supplier quality issues and adulterated products to investigate risk / harm associated with events addressing FDA finding.• Performed trend analysis from data to identify trends and escalate to ERB / CAPA decreasing corrective action time in the field.

Invacare

Investigated and reported complaints about a reportable and non-reportable event within the FDA guidelines• Determined reportable events and developed training tools for staff leading to continuity within reporting.• Investigated Level 3 injury involvement complaints with Legal.• Led MDR staff regarding reportability aspects to the FDA and Health Canada.• Created and updated reportability for devices in conjunction with harms hazards risk documents for continuity of reportable and non-reportable events decreasing the number of Reportable events.• Managed remediation backlog taking 100,000 complaints to 10,000: backlog of late MDR (day 60 plus) to being current at day 8-10 to ensure completion of all reportable events in accordance with 21CFR803.• Completed investigations regarding different levels of problems to conform to FDA guidelines of reportability leading to a compliant process. • Create instructions, protocols and NCM for remediation of backlog of complaints expediting the closure of the 100,000 open complaints in backlog• Formatted FDA regulations for ISO14971 & 13485 into local procedures to adhere to CFR guidelines to address 483 findings.

Headed quality for the organization including microbiology, analytical lab functions and process improvement modalities. • Maintained quality control for all incoming components, raw materials, and corrugated material as well as bulk, bulk pack and finished goods. • Implemented proper aspects of document control and organized manufacturing procedures throughout the company to ensure cGMP compliance.• Upgraded analytical lab with a new HPLC instrument and updated all validation procedures. Ensured quality throughout the manufacturing process starting with incoming receipt to shipment of finished goods. • Implemented new HPLC Method development for incoming inspection of raw materials to ensure finished products meet labeling specification.• Organized and numbered manufacturing procedures resulting in proper cGMP.• Implemented non-conformance tracking and root cause analysis to ensure accountability of finished goods.• Implemented Lean Manufacturing starting with 5s impacted purchase of materials to decrease.• Installed wastewater treatment system in accordance with EPA to ensure compliance with Summit county water waste process.

Managed quality for the organization including microbiology and analytical lab functions. Maintained the quality control for all incoming components, raw materials, and corrugated material as well as bulk, bulk pack and finished goods• Achieved three successful FDA audits without any 483 findings. • Implemented proper aspects of document control and the organization of manufacturing procedures throughout the company leading to proper cGMP.• Upgraded the analytical lab with new HPLC instrument and updated all validation procedures. Ensured quality throughout the manufacturing process starting with incoming receipt to shipment of finished goods. • Implemented non-conformance tracking and root cause analysis throughout all divisions of the company installing a cGMP process improving compliance. • Implemented new OTC / SPF product line and testing:• Maintained third party/partner contract terms. Launched new product line giving the company partnerships with Coke and Mattel• Placed standards for products as well as components to bring cGMP compliance within the organization

Cleveland/Akron, Ohio Area

Headed mobile operations for the collections department and performed as SME for collection procedures. Maintained daily operations for 19 counties. Managed operations of projected 800 plus units per day collections within 19 counties of Northern Ohio to successfully meet the needs of the community. • Maintained customer satisfaction with improvements of system for better overall compliance leading to increase donations.• Oversaw compliance for regulated and non-regulated procedures for 200+ staff in the collections department, and implementation of BSD, BSL and follow up on all 483's.• Implemented regulatory directives from National Headquarters consisting of project management for cross-departmental compliance. • Followed-up on difficult investigative deviations for root-cause and correct measures to correct within the preventative action plan.• Achieved track record in passing FDA and internal quality audits.• Changed vehicle equipment to decrease the strain on drivers with heavy containers.• Organized largest single annual blood drive in Ohio leading to improved overall donor satisfaction.• Completed all training of constant regulatory changes and completed customer service course.• Certificate of Completion for Donor Strategy Conduction Effective Operations Train the Trainer Program.• Implemented a Medical device design change (blood needles) decreasing number of accidental needle sticks.

Doctor Of Medicine (Md), Family Medicine Residency Program, Pass

Activities and Societies: American Medical Student Association Program; Externship in Pediatric Neurosurgery

Bachelor Of Science, Microbiology, General

Studied Microbiology, Teacher Assistant,

Bachelor Of Applied Science - Basc, Microbiology And Immunology

Bachelor Of Applied Science - Basc, Microbiology And Immunology, 3.75