Specialist, Compliance (Temporary)

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

About Us: Baxter’s Mission:

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Together, we build a place where we are happy, successful, and encourage each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

Your role at Baxter!

Maintain compliance with corporate, FDA, ISO 13485, MDSAP, and other regulations. Handle assessment duties: Conduct internal audits, coordinate resources for efficient preparation, implementation, and reporting of external audit results, and monitor the accuracy and sufficiency of quality systems, procedures, and practices. Head Quality Trends, Audit Review, and Management Review Meetings. Co-lead the ICARE Program implementation at the site.

Serve as a mentor for investigation owners in audit responses.

What you'll be doing:

• Manage resources and coordinate activities of the Internal and External Audit process.
• Supervise the preparation of the internal audit schedule every year.
• Coordinate the audit/assessment process with a group of plant-certified auditors, collecting and analyzing objective evidence regarding issues and risks.
• Report findings to management and assure internal audits are performed within the scheduled timeframe.
• Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness.
• Mentor and coordinate investigation owners in leading all aspects of investigations and their accurate documentation.
• Follow up to ensure Audit Observation Reports are received and completed within the established timeframe.
• Confirm corrective and preventive action efficiency and report extended corrective actions to management.
• Maintain External/Internal Audit files and Auditors Qualification records updated and available.
• Assist in the execution and completion of the Certification Document Review (CDR).
• Coordinate/support regulatory requests with the accurate resource to ensure timely performance and submission.
• Participate in the development and delivery of GDP training programs and conduct cGMP training for new employees, providing annual cGMP training to all employees.
• Lead external inspections from ISO, FDA, Customers, MDSAP, MDR, and others, maintaining accurate communication and crafting an atmosphere of credibility and confidence.
• Maintain the Internal/External Audit metrics and report to Management as per established guidelines and as needed.
• Report plant metrics in the Global system monthly.
• Lead training program on Regulatory Standards like 21 CFR 820, ISO 13485, MDSAP, MDR, and other relevant regulations.
• Co-responsible for ICare Program implementation at Haina.

What you'll bring:

• Bachelor’s degree in industrial engineering related career.
• Five (5) years’ experience in Quality, including at least two (2) years of experience in Auditing Techniques, Regulations, and ISO 13485 and 9000 Standards.
• Preferred candidate will hold American Society for Quality (ASQ) Certified Quality Auditor (CQA) certification or equivalent experience.
• Knowledge in GDP’s, GMPs, 21 CFR Part 820 - Medical Device Quality System Regulation (QSR), ISO 9001, MDSAP, and ISO 13485 Standards.
• Proficiency in Microsoft Office Software.
• Knowledge in Specs/SOP’s creation.
• Familiarity with OSHA, GMP, General FDA Regulations, Good Documentation Practices, CAPA, Internal Audit, and Training.
• Bilingual (English and Spanish).

At Baxter Healthcare Corporation, we value diversity and are committed to being an equal opportunity employer. We do not discriminate based on race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. If you need accommodations during the application or interview process, or to perform essential job functions, please contact us.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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