Quality Data Auditor
Baxter - Medina, NY
Req ID: 60705BR

Business Title: Quality Data Auditor

Business: Medical Products

Sub-Business: Fluid Systems

Country: US

State/Province: New York

Location of Position: Medina, NY

Shift: 1st

Job Description:
FUNCTIONAL RESPONSIBILITIES

Maintain and continuously improve the Baxter Medina Quality System program through comprehensive internal audits.

Track internal audit non-conformances to completion.

DIRECT RESPONSIBILITIES:
Maintain the internal audit schedule.

Schedule internal audits for the facility.

Maintain the list of the qualified internal auditors.

Conduct internal audits e.g. initiating the audit, conducting document reviews, audit planning and preparations, conducting opening and closing meetings, collecting and verifying information, generating audit findings, preparing audit conclusions, preparing the audit report as well as all established post audit activities as required.

Schedule and track internal audit results and responses. Ensure all discovered nonconformities are tracked and completed in a timely fashion.

Performs follow up internal audits to confirm that the corrective and preventive actions are effective.

Maintain current in regulatory trends and provide feedback to the quality system based on the information.

Provide evaluation of external standards and regulations.

Provide training on regulations standards as needed.

Provide support for external audits.

Maintain the internal and external audit metrics for management review.

Job Requirements:QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED:
This role requires extensive personnel interaction, including all functions and all levels of the organization.

Must have computer proficiency with solid experience in Microsoft Word, Excel, and Access or other database programs.

Experience in maintenance of Internal Audit Nonconformance tracking

Ability to work effectively as part of a cross functional team

Ability to relate and work well with people

Excellent organizational skills

Excellent presentation skills

Excellent verbal/written communication skills

Attention to detail

Ability to multi-task and work well under pressure

EDUCATION/EXPERIENCE REQUIRED:
BS in science or technical field or equivalent work experience, MS a plus

Five years working experience in the medical devices or other FDA regulated industry, three years experience as an auditor.

CQA Certification or RAB ISO 13485 Certification is required

Working knowledge of Quality Systems and related requirements and standards, including 21 CFR Part 820, ISO 13485

Working knowledge of other medical device regulatory requirements (US, Canada and Europe) highly desirable

Prior Quality Experience is preferred

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.

Baxter - 11 months ago - save job - block
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About this company
282 reviews
axter International Inc. (NYSE: BAX), is an American health care company with headquarters in Deerfield, Illinois. The company primarily...