Karen Sanchez
Escondido,CA
Summary
Equipped with strong problem-solving abilities, willingness to learn, and excellent communication skills. Poised to contribute to team success and achieve positive results. Ready to tackle new challenges and advance organizational objectives with dedication and enthusiasm.
Overview
18
18
years of professional experience
Work History
Quality Assurance Technician II
Sendx Medical Inc.
05.2015 - Current
- Coordinate all required paperwork necessary to ensure quality compliance of Acceptance activities. E.g. (Receiving inspection, first article reports, QA final inspection)
- Used measuring tools (calipers, micrometers, gauges) to verify dimensional accuracy.
- Ensured compliance with industry standards (ISO, AS9100, FDA, etc.).
- Adhered to safety protocols while handling hazardous or sensitive materials.
- Develops, collects, and communicates quality metrics that measure the efficiency and effectiveness of
- Provide feedback regarding documentation / data requirements supporting completion of quality documents.
- Monitoring and aiding the implementation of continuous improvements and process changes to ensure these are implemented in compliance with GMP.
- Utilizing Danaher Business System (DBS) concepts and tools in the performance of daily activities.
- Support internal and external audits.
- I review and update SOPs, WI (Work Instructions) as needed.
- Create, analyze, and take action to own and process Non-Conformance Reports (NCRs).
- Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports.
- Proactively manage MRB and ensure appropriate materials handling on a timely manner
- I create, analyze, and take action to own and process Engineering Change Orders (ECOs).
- Work within an EDMS (Electronic Document Management Software) such as Master Control.
- Work within an ERP (Enterprise Resource Planning) such as Axapta.
- Proficiency in Microsoft Word, Excel, Outlook, and PowerPoint.
- Provide guidance to others concerning documentation completeness, accuracy, GDP, as well as related manufacturing quality management systems and processes
- Interface with the Manufacturing department to coordinate product release activities to best support production build and shipping schedules.
- Continually identify, recommend, and implement process improvements.
- Responding to routine quality related queries from other departments.
- Assist with Sendx training sessions to meet and improve Quality System goals.
- Led root cause analysis initiatives to identify process inefficiencies and recommend improvements for quality control measures.
- Performed thorough inspections of incoming materials and outgoing products.
- I have knowledge of 5s, kaizen, Kanban system, as well as lean Manufacturing techniques.
- Provided training on quality assurance best practices for new employees, fostering a culture of excellence within the organization.
QA Technician
Medtronic Ablation Frontier.
08.2013 - 05.2015
- Assembly caterers
- Inspection
- Work within an ERP (Enterprise Resource Planning) such as SOP
- Used various measuring tools
- Verify quantities and filing documentation
- Maintain records of products
- Assist in other areas and departments as needed
- Process orders to make sure they compliance with company policy
Lead and Warehouse Clerk
CareFusion
02.2007 - 06.2013
- Stocking inventory and lift up 50 lbs.
- Forklift certified
- Verifies and enters all data from orders into computer
- Word and excel processed correspondence and documentation
- Maintained file system, retrieved file on request
- Provide customer service to incoming callers and answer emails with regards to the company
- Tracks order using the UPS website and follow up with freight carriers
- Working with domestic and international orders verifying shipping orders
Education
Associate of Science - Engineering
Palomar College
San Marcos, CASkills
- Over 15 years’ experience in the medical device industry
- Computer skills: Word, Excel, and Outlook
- Experience with ERP (Axapta, Oracle and SAP)
- Oral and written communication skills
- Strong attention to detail and ability to learn fast
- Bilingual: English and Spanish
- Inventory control skills
- Multi-task oriented
- Auditing
- Documentation skills
Timeline
Quality Assurance Technician II
Sendx Medical Inc.
05.2015 - Current
QA Technician
Medtronic Ablation Frontier.
08.2013 - 05.2015
Lead and Warehouse Clerk
CareFusion
02.2007 - 06.2013
Associate of Science - Engineering
Palomar College
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