Job Description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries

JOB DESCRIPTION:

Purpose:

Establish and maintain effective structures to ensure consistent implementation of quality systems at Abbott. Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidances and standards.

Responsibilities:

* Responsible for compliance with applicable Corporate, Divisional, and site Policies and procedures.
* Identify internal requirements and external laws, regulations, guidance documents and standards (LRGS) applicable to Abbott quality system.
* Interpret applicable internal requirements and external LRGS and incorporate into requirements for use in Abbott business processes.
* Identify areas of potential noncompliance within Abbott.
* Supports internal and external audits such as audit coordination on-site, set-up, request tracking, and other audit related tasks.
* Review and update the Quality System Manual, Quality Agreements, and quality plans as needed.
* Check or audit the work of others for compliance to the Abbott Quality System
* Establish new and modify existing documentation using the Abbott Change Control process, ensuring documents are compliant to internal requirements and LRGS.
* Accountable for the timely implementation of all documentation necessary to complete tasks. To minimize errors which could negatively impact product or product documentation, accuracy and attention to detail is expected.
* Identify quality improvements and develop suitable corrective actions.
* Educate functional areas on quality system requirements.
* Participate cross functionally and across business units to standardize Abbott business quality system policies and procedures.
* Collect business process data from different parts of the company for analysis. Present data to cross-functional audience.
* Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks.
* Demonstrate basic project management skills by acting as a project lead on small, well defined projects.
* Plans, organizes, and prioritizes own daily work routine to meet established schedule.
* Exercises authority and judgment within defined limits to determine appropriate action and understands when a decision to be made is outside scope of authority and be able to effectively communicate to appropriate level for resolution.

Minimum Education & Experience:

* Bachelor's degree or equivalent work-related experience required.
* Minimum 1 years in an FDA regulated environment, quality control, document control, compliance, auditing, engineering or regulatory

JOB FAMILY:

Quality Assurance

DIVISION:

AVD Vascular

LOCATION:

United States > Westfield: 1820 Bastian Court

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Yes

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf