Quality Director

Company: Baxter International Inc.
Location: Opelika
Posted on: September 20, 2022

Job Description:

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. The Site Quality Director will understand, implement, maintain, and continually improve the effectiveness the Baxter Quality Management System for the Opelika, AL plant. They will assure systems, processes, and procedures for regulatory compliance are established and deployed while serving as the Quality Management Representative for the plant. Essential Duties and ResponsibilitiesEnsuring that QMS requirements are effectively established and maintained.Delegating authority to personnel responsible for various aspects of the QMS.Reporting on the performance of the QMS and any need for improvement to the highest level MWER.Ensuring field surveillance activities are executed.Ensuring product safety risks are effectively evaluated, managed, communicated, and documented.Maintaining the integrity of the QMS when changes to the QMS are planned and implemented.Ensuring the promotion and awareness of regulatory and customer requirements throughout the organization.Ensures that there is an independent quality unit (independent from manufacturing) or process that defines the responsibility and authorityApproving or rejecting components, containers, closures, in-process materials, packaging material, labeling, and final products.Ensuring and maintaining the GMP compliance status for their sites, per the applicable regulations and relevant GMP activities.Reviewing production/quality records to ensure that exceptions have been appropriately addressed.Approving or rejecting procedures or specifications impacting the quality and performance of the product.Approving or rejecting products manufactured, processed, packed, or held under contract by another company.Be an example of the Baxter mission: collaboration, speed, courage, and simplicity.Education and/or Experience:BS in science or engineering required 10+ years of experience in Quality, Manufacturing or related fields in the medical products industry. 7+ years of management experienceIntermediate level of desktop publishing skills and document management software skills for product/document configuration.Proficient skills in data integrity and impact assessmentExcellent conceptual, analytical, written and verbal configuration skills.Comprehension of design methodology, product configuration and complex manufacturing processes.Must be a strong team player with good problem solving, and good verbal and written communication skills.Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Manufacturing Practices.Initiating the Field Actions process and approving the final Field Action decision.Ensuring that regulated activities, not directly managed by the quality unit, are controlled by appropriate quality processes, andElevating issues or concerns to higher level QMRs and/or MWERs for review.Maintaining the Management Review process for their entity#LI-SL1The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.Equal Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. EEO is the Law EEO is the law - Poster Supplement Pay Transparency PolicyReasonable AccommodationsBaxter 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.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Keywords: Baxter International Inc., Columbus , Quality Director, Executive , Opelika, Georgia