Abbott Document Specialist II - Abbott Diabetes Care in Alameda, California

At Abbott, we're committed to helping you live your 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, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.

JOB DESCRIPTION:

Primary Function

Assist in developing and maintaining systems within the Document Control department that include Document Control function and Data Management. Maintain software databases supporting quality system data. Responsible for maintaining the Engineering Change Order system. Changes will include product improvements, design corrections and new product development.

Main Responsibilities

Essential functions:

Create, analyze and process Engineering Change Orders (ECs) in compliance with FDA, QSR, ISO9001, ISO13485 and Abbott standards.

Additional Responsibilities:

Assist in maintaining a company wide Data Management System.

Create, analyze and process ECs for new product development and upgrades while coordinating EC activity for Document Control.

Coordinate ECs through the department in preparation for the Change Control Board (CCB) review and approval process.

Assist in resolving moderately complex issues, provide judgments and recommendations to manager.

Assist in defining and documenting EC procedures and standards.

Provide customers (internal and external) technical assistance in Change Control procedures.

Accountability / Scope / Budget

Please describe accountabilities.

Responsible for interfacing between Engineering, Manufacturing, Operations, Marketing, etc., to ensure the appropriate changes are documented.

Has a thorough understanding of impact of material dispositions (in ECs) on Production, Purchasing, Planning ans suppliers.

Works with the affected departments to ensure correct dispostions are assigned in ECs.

Minimum Education & Experience

B.S. degree or equivalent. Related experience with Document Control and Change Order systems is required, preferably in a regulated environment such as medical devices industry. Working knowledge of QSR, ISO, standards relating Document and Data Control. Prefer experience with Agile software. Strong interpersonal and communication skills. Works effectively with others while providing high level customer service. Works moderately independently requiring only moderate supervision. Sustains moderate to high judgement on moderately complex non-routine tasks. Able to prioritize work. Exercises judgement with defined procedures and practices to determine appropriate actions.. Makes task related decisions daily.

JOB FAMILY:

Operations Quality

DIVISION:

ADC Diabetes Care

LOCATION:

United States > Alameda : 1360-1380 South Loop Road

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

No

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

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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