Job Details

Quality Analyst/Quality Engineer

Company name
Laboratory Corporation of America® Holdings

Location
Burlington, NC

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Quality Analyst/Quality Engineer

in

Burlington

North Carolina

Quality Analyst/Quality Engineer

Burlington North Carolina

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Requisition Number

17-81031 Date posted

09/09/2017

Shift

1

Work Schedule

8:00am - 5:00pm Monday - Friday

Job Description

The MEDTOX Diagnostics division of LabCorp is seeking a Quality Engineer. This position will perform a variety of duties in accordance with established policies and procedures to support the quality management system and ensure compliance with FDA medical device regulations.

Key Responsibilities Include:

Perform validations of equipment, processes/products, and software (includes protocol and report preparation)

Manage Equipment Control documentation systems, including interface with Facilities and document approval

Perform equipment failure investigations

Assist with creating and maintaining controlled documents as needed to support the quality management system

Perform problem investigations and root cause analysis for internal and customer-related corrective actions, including participation in cross-functional teams

Lead projects and participate in project teams for internal projects, including new product development and product/process improvements

Analyze data and prepare and present data analysis for product/process performance issues and other areas as needed to support improvement efforts, troubleshooting, and corrective action

Assist with on-site audits of suppliers

Requirements

Required Education:

B.S. degree in Engineering or science field

Preferred Experience:

2 years of Quality Engineering experience

Equipment/process validation experience

Manufacturing experience, preferably in medical device or other regulated industry

Working knowledge of medical device FDA and ISO 13485 requirements

Strong written/verbal communication and problem solving skills

Strong knowledge of root cause analysis and risk assessment processes

Proficient in Microsoft Office Suite

Ability to manage multiple projects independently or as part of a team

Experience as an internal or external auditor

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Laboratory Corporation of America

Laboratory Corporation of America Jobs

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Company info

Laboratory Corporation of America® Holdings
Website : https://www.labcorp.com

Company Profile
LabCorp provides leading-edge medical laboratory tests and services through a national network of primary clinical laboratories and specialty testing laboratories. With scientific expertise in esoteric testing, genomics, and clinical and anatomic pathology, LabCorp processes tests on approximately 470,000 specimens each day, applying advances in medicine and science to laboratory testing.

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