Req ID: 60705BR
Business Title: Quality Data Auditor
Business: Medical Products
Sub-Business: Fluid Systems
State/Province: New York
Location of Position: Medina, NY
Maintain and continuously improve the Baxter Medina Quality System program through comprehensive internal audits.
Track internal audit non-conformances to completion.
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
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.
axter International Inc. (NYSE: BAX), is an American health care company with headquarters in Deerfield, Illinois. The company primarily...