Quality Assoc II
Baxter - Guaynabo, PR

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Req ID: 62159BR

Business Title: Quality Assoc II

Business: Global Human Resources

Country: Puerto Rico

State/Province: Guaynabo

Location of Position: Guaynabo - Rexco Ind Pk, PR

Shift: 1st

Job Description: Position is responsible for the implementation, deployment and maintenance of the Quality System throughout the organization, and assuring that all applicable government regulations and Baxter’s Quality Assurance and Regulatory Affairs’ requirements are met and translated into local operating procedures.

Support management to identify and escalate issues

Perform trend reporting and escalate results to appropriate business units for consideration of necessary actions

Participate in process improvement activities and projects

Ability to perform all duties required of previous levels.

Support management in activities of the Quality unit.

Manage Complaints, FCA’s, and Product Surveillance systems for products and services provided. Implements quality system and regulatory procedures and assures compliance to requirements.

Understands and assures conformance to local, federal and government regulations (including those of markets outside the US) as applicable to sales and distribution centers. Interfaces with personnel from regulatory agencies during inspections.

May participate in or manage quality assessments of internal operations, suppliers and third party logistic supplier to analyze compliance and assess risk.

Interacts frequently with functional peers and senior group managers.

May interactions with regulatory agencies representatives and customers to represent the company products and processes.

The incumbent will perform other duties assigned.

Responsible to inform unsafe behaviors and also recommend safety measures to the appropriate department

Job Requirements: A minimum of an Associates Degree required in nursing, pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN).
Bachelor degree and /or clinical certification (MT, RN) preferred.
Preferably with 0-3 years work experience in a cGMP industry environment.

Doing Work that Matters: Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.careers.baxter.com/. EOE M/F/D/V.

About this company
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axter International Inc. (NYSE: BAX), is an American health care company with headquarters in Deerfield, Illinois. The company primarily...