Customer Service Medical Device

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

Mobile 562-***-****

*********@**********.***

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 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, customer service, ophthalmic supplies, dental and technical support.

Experience in emergency services allows me to handle difficult and trying situations.

Have established and maintained quality operating procedures within a customer service, manufacturing & sales environment.

Understand the technical processes and applications throughout a work group.

Assisted in development and maintenance of efficient record-keeping systems that enable fast and easy access to needed information. Verified records, policies, and procedures which cover the entire life span of data from creation to storage to destruction. Confirmed that all data was input with accuracy.

Ensured all protocols are followed and that all shipping documents are always in order.

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

Event Staff – Usher

Angel Stadium, 2000 Gene Autry Way, Anaheim, CA 92806, 714-***-****

Part-time seasonal from 09/23 – to present.

Support baseball games, concerts, conventions, college sports, and other special events from in and around the Orange County Region. Crowd Management for the entertainment, sporting, and convention Industries.

Event Staff - Nationally recognized as an industry leading crowd management, event staffing, and consulting company.

Allied Universal Event Services, 5455 Garden Grove Blvd, #600, Westminster, CA 92683, 714-***-****

Part-time from 3/23 to present.

Assist with screening of patrons of trade shows, expos, university events, concerts, and convention centers.

Coordinate and manage security, event staffing, and safety needs such as:

a.Access Control

b.Tickets Tacker/Scanner

c.Alcohol Enforcement – RBS Certificate #313339648

d.California State Food Safety Certificate # 1931kk-jeceaj3

Glidewell Dental Laboratories, 4141 MacArthur Blvd., Irvine, CA 92660, 800-***-****,

Full time two-month contract, 10/22 -12/22

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

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.52 Discovery, Irvine, CA 92618, 949-***-****

Full time from 12/15/15 to 03/06/2022

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

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.

Beckman Coulter, 4500 North Harbor, Fullerton, CA, 800-***-****

Full time from 06/15/2001 to 06/16/2005

Service Coordinator Dispatch – Manufacture, Sales, and Service of Medical Devices.

Created service requests for instrument repairs and forwarded them 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.

Beckman Coulter, 250 South Kraemer Blvd, Brea, CA 92821, 800-***-****

Full time 06/16/2005 to 11/11/2011

Client Services Contract Specialist – Manufacture, Sales, and Service of Medical Devices.

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.

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

RBS ABC (Responsible Beverage Server)

California Food Handlers Certificate

Montebello High School, Montebello, CA Graduate

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

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