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Quality Systems Specialist

Company: Abbott
Location: Charlottesville
Posted on: February 10, 2019

Job Description:

QUALITY SYSTEMS SPECIALIST
CHARLOTTESVILLE, VA

DO WORK THAT MATTERS

Join us at Alere Informatics - part of Abbotts Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

As we embark on this exciting journey, we are searching for a QUALITY SYSTEMS SPECIALIST to join our team. This is a great opportunity to leverage your strong technical expertise while growing your career with a premier industry leader. If you seek a dynamic role where your contributions will pave the way in developing exciting new products, then come and work with us!

This position will work at the Charlottesville, VA site within close proximity of the regions beautiful mountains and beaches,
we are within a few hours drive of the metro areas of Washington DC and Baltimore MD.

SUMMARY

This position will provide support to the Director, Quality and Regulatory Affairs, by proposing and implementing process improvements and maintaining and improving various quality system processes.

This job function has accountability for complying with the applicable elements of Global Quality and the ARDx Quality Management System (QMS).


TASKS AND RESPONSIBILITIES


* Quality Management System (QMS) Processes: Monitors and improves existing QMS processes to streamline and ensure compliance. Generates relevant metrics for these processes and reports the metrics to management.

* Document Control: Administers the electronic Document Management System(s) to ensure efficient organization, review, approval & delivery of documents, training of all users, implementation and validation of new system or upgrades to existing system, and compliance with all applicable standards. Writes, reviews and approves Quality System documents as necessary.

* Training: Administers the electronic training program to ensure adequate quality/regulatory training of all personnel. Works with management to define & document required quality training as part of the overall training program.

* Supports quality management by participating in other quality system processes, such as audits, CAPA or non-conformance. Acts as the Quality representative on cross-department and/or site teams, such as development, design change, etc.

* Other responsibilities as assigned.


QUALIFICATIONS

* Strong problem-solving skills and necessary persistence to work around roadblocks.

* Implements ARDx Standards / Procedures into the Informatics quality system.

* Implements Global e-enterprise systems into the Informatics quality system

* Carries out duties in compliance with established business policies.

* Demonstrates accountability for complying with local and global Quality System requirements.

* Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices.

* Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

* Bachelor's Degreein Engineering or relatedtechnical discipline is preferred and at least 3-5 years of experience in a Quality Systems role is required.

* Working knowledge and experience with FDA cGMPs/QSR and ISO QualitySystem requirements.

* Candidates with quality and/or regulatory compliance experience in the medicaldevice or biotech industry are preferred.

* American Society for Quality (ASQ) certifications preferred

* Perform other duties and projects as assigned.

*


ABOUT ABBOTT

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

AN EQUAL OPPORTUNITY EMPLOYER, ABBOTT WELCOMES AND ENCOURAGES DIVERSITY IN OUR WORKFORCE.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to myrecruiter@alere.com.

Keywords: Abbott, Charlottesville , Quality Systems Specialist, Other , Charlottesville, Virginia

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