Quality Assurance Customer Service

Experience overview

Engineering 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 control

Quality Assurance and Quality Management, IQMS

Inspection and testing

Customer Service

Education

Technical University Sofia, Bulgaria

Mechanical Engineering, Bachelor of Science and Masters of Science June 1996

Century College St Paul, MN, USA

Certification in Customer service, and Psychology August 2020

Hennepin Technical College Brooklyn Park, MN

Fundamentals of Plastics and Chemistry Fall 2008

Relevant Experience

DPI (Diversified Plastics Industries) Ramsey, MN

Quality Assurance January 2021 – recent

I’m 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, IP’s, 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 request

Delta ModTech Ramsey, MN

Quality Assurance April 2020 – November 2020

Dimensional inspection of machine parts and devices using various precise measuring tools, ensuring all mechanical parts meet contract blueprint specifications following ISO standard

Review machine part blueprints, procedures, and work instructions to complete inspection

Identify non-conforming parts and initiate corrective actions where required, or discard parts depending on nature and extent of defects

Maintain required data submission for each individual part and submit nonconformance quality reports for each defective part

Complete all necessary steps to ensure second ops for the required part are met

Work closely with engineering, process manufacturing and suppliers to maintain high quality

HOYA / Vision-EASE Worldwide Ramsey, MN

I 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 2020

Supported 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 records

Specialized in imaging (digital high-resolution microscope) and profilometers to create micrographs of various surfaces.

Trained personnel on various tests/test equipment

Supported root cause analysis and implementation of corrective actions to ensure proactive prevention of product defects, execute R&R Gages

Conducted experiments, collected, analyzed, plotted data and suggested fact-based key operational improvements to the production process

Created PowerPoint presentations to summarize and present the findings of the experiments

Worked 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 available

Worked 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 materials

Independently 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 services

Managed laboratory resources and equipment, as well as, ensured enough availability of testing inventory and personnel

Assisting in providing feedback and coaching direct reports, managing and evaluating performance, managing conflict, leading teams, employee engagement, and onboarding new employees.

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