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Experience overviewEngineering professional with a background in Quality Assurance, IQMS, ECOs and Document control.Review and approval of new work instructions and blueprints, and maintaining updates of existing ones.Managing electronic files and paper copies of IR, FAIRs, deviations, MRB records and etc.Sufficient in Templates, Forms and CoC and CoA creation, review and approval. Experienced in Research and Development, and Metrology. Familiarity with materials, tools, measurement equipment, and production process design principals.Effective professional that drives toward achieving business goals. Comfortable working with all levels of employees and teams within an organization. Known for professionalism, self-motivation and ability to perform in various projects.Industry knowledge and competencies:Documentation and Doc controlQuality Assurance and Quality Management, IQMSInspection and testingCustomer ServiceEducationTechnical University Sofia, BulgariaMechanical Engineering, Bachelor of Science and Masters of Science June 1996Century College St Paul, MN, USACertification in Customer service, and Psychology August 2020Hennepin Technical College Brooklyn Park, MNFundamentals of Plastics and Chemistry Fall 2008Relevant ExperienceDPI (Diversified Plastics Industries) Ramsey, MNQuality Assurance January 2021  recentIm responsible for ensuring that Diversified Plastics Inc. (DPI) Quality Documents meet DPI, customer and regulatory requirements.Assisting with the documentation workflow management within the organization.Responsible for the Engineering Change Order (ECO) process to ensure quality production per customer specifications.Maintain current revision and history of all Device History Records (DHR), Blueprints, IPs, FAIR, deviations, MRB, CAPA, Raw material records and training records.Oversee label accuracy for medical parts shipped locally in USA, Europe and South America.Creation of certs such as Certificates of Conformance and Certificates of Analysis by customer requestDelta ModTech Ramsey, MNQuality Assurance April 2020  November 2020Dimensional inspection of machine parts and devices using various precise measuring tools, ensuring all mechanical parts meet contract blueprint specifications following ISO standardReview machine part blueprints, procedures, and work instructions to complete inspectionIdentify non-conforming parts and initiate corrective actions where required, or discard parts depending on nature and extent of defectsMaintain required data submission for each individual part and submit nonconformance quality reports for each defective partComplete all necessary steps to ensure second ops for the required part are metWork closely with engineering, process manufacturing and suppliers to maintain high qualityHOYA / Vision-EASE Worldwide Ramsey, MNI was an employee of HOYA (formerly known as Vision-EASE Worldwide) for over 15 years in a variety of roles including research and development, operations, and quality assurance.I was promoted three times throughout my tenure.Principal, Research and Development June 2005  March 2020Supported new product development and improvement of existing products through optical and mechanical tests and statistical analysis. For the supporting analysis I used Excel and Minitab.Developed testing methods and recorded best practices in Doc Control Work instruction directory for future replication and recordsSpecialized in imaging (digital high-resolution microscope) and profilometers to create micrographs of various surfaces.Trained personnel on various tests/test equipmentSupported root cause analysis and implementation of corrective actions to ensure proactive prevention of product defects, execute R&R GagesConducted experiments, collected, analyzed, plotted data and suggested fact-based key operational improvements to the production processCreated PowerPoint presentations to summarize and present the findings of the experimentsWorked closely with Project Managers, Ph.D.s, and Senior Scientists to create/accommodate the testing schedule and ensure the timeline is met and resources needed are availableWorked with HOYA internal marketing and sales team and local and international suppliers and vendors to ensure a fair comparison of the testing procedures and use of standard materialsIndependently executed marketing studies/ customer surveys to grade new products.Participated to Six Sigma, and Lean manufacturing team meetings with the aim to increase efficiency, and improve quality and lower the price of the products and servicesManaged laboratory resources and equipment, as well as, ensured enough availability of testing inventory and personnelAssisting in providing feedback and coaching direct reports, managing and evaluating performance, managing conflict, leading teams, employee engagement, and onboarding new employees.