**** ********** ****, ** *****, CA *****

Mobile 562-***-****

ad000z@r.postjobfree.com

Barbara Lynn Burruel

Goal

Seeking a position where an experienced, detail-oriented professional, can apply skills acquired from years of support within a quality managed medical device industry. Drive and focus on results, take initiative with limited direction and take ownership for work within scope. Believe my conscientious, intuitive & straightforward expertise can assist in any customer relationship environment.

Professional Experience

Numerous years of service in the medical device industry including compliance, sales, contracts, service, ophthalmic supplies, technical support and emergency services.

Established and maintained the quality operating procedures within a customer service, manufacturing & sales environment.

Understand the technical processes and applications throughout a work group.

Knowledge of the principles of Quality Control (QC) and/or Inventory Control.

Understand Microsoft Office, SAP, ERP, Agile, EDI, CRM, Oracle, etc.

Knowledge of Federal and State Laws and Regulations related to a medical device industry, including ISO production standards, GMP, cGMP, Lean Six Sigma, Corrective Action and Preventative Action Processes (CAPA) and the fundamentals of Total Quality Management (TQM) as it relates to a product and/or service quality system.

Experience

Glidewell Dental Laboratories Irvine, CA 10/22 – 12/22

Quality Complaint Specialist – Manufacture, Sales and Service of Dental Devices– Direct Hire

Evaluates event(s) to determine if it qualifies as a complaint.

Manage customer relationship and expectations during complaint investigation and resolution process.

Reviews potential reportable events to determine if regulatory filings are required.

Ensure compliance with all federal regulations applicable to manufactured dental devices.

Performs other related duties and projects as business needs require at direction of management.

Masimo Corp. Irvine, CA 12/15 – 03/22

Quality Complaint Specialist – Manufacture, Sales and Service of Medical Devices. – Direct Hire

Perform preliminary classification of complaints that require additional review for reporting (e.g. Medical Device Reporting, Medical Device Vigilance or other event reporting for International Bodies worldwide).

Ensure all potentially reportable complaints are escalated to appropriate levels of the team and management.

Evaluate documentation for completeness, consistency, and assign additional actions as necessary to prepare for closing team.

Ensure that all complaints requiring customer responses are properly addressed. Follow-up with all product returns.

Mindlance, Inc – Recruiting Agency/ Beckman Coulter Hoboken, NJ 05/15 – 10/15

Contract Specialist – Contract Position at Beckman Coulter, Brea, CA.

Worked through ORACLE Order Management system to process various order transactions.

Work with customers to coordinate returns of instruments or consumables.

Research disputed invoices for corrective action.

Prepare communication to customer on delayed shipments.

Effectively communicate with other departments to resolve issues.

Various Long Term and Contract Assignments- Orange County, CA 12/11 – 05/15

Spireon, Inc / Experis Engineering/ Integra LifeSciences, Inc

Tier 1 Technical Support/ Customer Service

Provided on-call technical support for lenders, dealers and fleet operations with GPS navigational systems. Responsible for handling incoming customer problems, investigation, and plan for resolution that meets the agreed Service Level Agreements.

Responsible for work processes that streamline operations, boost field worker productivity and enhance customer service experience. Entered inventory items into database, materials, components and sub-assemblies to be incorporated into a final product.

Entered quotes and invoiced all engineering projects in-process and upon completion.

Processed customer complaints, initiated complaint form and sent paperwork to appropriate department. Followed up with customer with correspondence explaining findings, corrective action, update log and monitored until closure.

Process orders via Oracle for orthopedic, plastic and general surgeons, hospitals, distributors and sales representatives.

Monitor and replenish consignment inventory as per capital equipment contract.

Track back-orders; invoice; credit and re-bill as necessary.

Beckman Coulter, Brea, CA 06/01– 11/11

Client Services Contract Specialist – From 05/16/2005 – 11/01/2011

Scheduled the decontamination of returning instruments and arranged their removal.

Entered part and reagent orders for; customers, field service engineers and sales personnel.

Followed procedures for all nonconforming products, including complaints and corrective/preventative action activities.

Worked as liaison between field service engineers, sales representatives and customers.

Service Coordinator Dispatch – From 06/25/2001 – 05/15/2005 at Fullerton, CA facility

Created service requests for instrument repairs and forwarded to appropriate field engineer.

Entered part orders for; field service engineers, sales and customers and EDI orders.

Initiated Customer Feedback reports and forwarded to correct personnel.

Research contractual status of each call for instruments requiring routine maintenance and/or modifications as needed.

Education

2010 - 2011 North Orange County Community College District, School of Continuing Education, Anaheim, CA

Completed course for Quality Assurance Management Certificate for Medical Devices:

Curriculum included:

Quality Assurance for Medical Devices

Technical Writing for Medical Devices

Quality Auditing for Medical Devices

Regulatory Affairs for Medical Devices

Document and Database Management for Medical Devices

Montebello High School, Montebello, CA Graduate 1972

Volunteer Dispatcher with La Habra Heights Volunteer Fire Department 1986 - 2016

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