Nelly Bohorquez
Tustin,CA
Summary
I am a dedicated Quality Inspector with over 15 years of experience in quality control, particularly in the medical device industry. I have a strong background in managing non-conforming materials, conducting detailed inspections, and ensuring compliance with manufacturing specifications. I am proficient in using various measuring tools and have significant experience working in clean rooms. I am committed to maintaining high standards of quality and safety and am looking to continue my career in the field of quality inspection.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Quality Control Inspector
Balt Group
09.2024 - Current
Quality Inspector
Medtronic Neurovascular (formerly Covidien)
02.2013 - 03.2024
- Performed detailed quality inspections using microscopes with magnifications ranging from 4x to 60x, ensuring precision and accuracy in evaluating components and finished products.
- Managed non-conforming materials, ensuring relevant departments were notified and assisted in the final disposition.
- Utilized precision tools such as micrometers, calipers, pin gauges, and microscopes to inspect and assemble medical devices, ensuring strict adherence to product standards and regulatory requirements.
- Assisted quality engineering in product design verifications and process qualifications/validations.
- Read and interpreted assembly drawings, SOP’s, visual aids, and other applicable company documents. (ISO 13485)
- Inspected incoming and outgoing materials for physical damage or defects.
- Processed medical receipts and finished goods shipments.
- Verified all products against purchase orders or packing slips for order accuracy.
- Ensured proper packaging, identification, and lot control of all products.
- Verified and approved labels, reviewed LHR, generated NCMR reports, and entered data in QAD, SAP and SAGE enterprise systems.
- Scheduling sterilization loads , GAMMA, EO and dry heat .
- Performed and Review Pre-Post sterilization paperwork, performed final product release by reviewing Sterilization reports, LAL pyrogen tests, Bioburden and Biological indicator tests.
- Generated Quality Control Certificates and Certificates of Analysis.
- Conducted dimensional/functional inspections and tests.
- Reviewed in-process subassemblies and finished product manufacturing routers for accuracy and completeness.
- Identified and implemented changes to quality systems and compliance procedures to ensure their continued suitability and effectiveness.
- Trained inspectors on inspection techniques and procedures and maintained updated training records.
Education
Surgical Technician -
Newbridge College
Santa Ana, CALicensed Vocational Nurse (LVN) - undefined
La Merced
Bogotá, ColombiaHigh School Diploma - undefined
ColombiaSkills
- Extensive clean room experience
- Proficient in using various measuring tools, including microscopes, micrometers, calipers, pin gauges, snap gauges, scales, TAPPI charts, VIS, and Nikon inspection tools
- Self-motivated, organized, detail-oriented, and adaptive
- Knowledgeable in inspection and sampling methods (C=0 Sampling Plan) (ANSI)
- Strong organizational skills, with a focus on filing and documentation
- Proficient in Microsoft Word and Excel
- Manual dexterity with excellent eye/hand coordination
- Experience working with health and safety hazards associated with production materials and equipment (MSDS)
- Set up and calibrated measuring and test equipment
- Ensured a safe and effective work environment by participating in safety training and maintaining good housekeeping practices within 5S guidelines
- Able to work with minimal supervision
Certification
- ASQ Orange Empire Section Certified Medical Auditor Refresher Course - Irvine, 2017
- Safety, Compliance, and Organization Award 5S - Covidien, Irvine, CA, 2012
Languages
English
Timeline
Quality Control Inspector
Balt Group
09.2024 - Current
Quality Inspector
Medtronic Neurovascular (formerly Covidien)
02.2013 - 03.2024
Licensed Vocational Nurse (LVN) - undefined
La Merced
High School Diploma - undefined
Surgical Technician -
Newbridge College