.**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.JOB SUMMARY:Demonstrates leadership in support of Hill-Rom's values, mission and objectives. Provides leadership in Quality Assurance in to the production department. Ensures compliance to the local procedures. Demonstrates a teamwork approach in maintaining professional relationships with internal and external customers, including regulatory and certifying agencies. Establishes priorities to best serve customers, as well as business needs. Leading different initiatives as cost reduction, continues improvements projects and maintain a good team work environment.ESSENTIAL DUTIES AND RESPONSIBILITIES: - Other duties may be assigned:- Provides leadership and oversight for the development and coordination of the quality and regulatory strategy for the site.- Oversees product development compliance. Responds to regulatory issues concerning products and business processes.- Works with inside and outside legal counsel in providing regulatory services to the facility.- Participates in special projects and initiatives, as requested.- Manages customer complaint process, including review, trending, and internal / external customer feedback.- Reviews and define business critical operating measures, and assures that any noncompliance associated with manufacturing processes, audit findings, complaints, design processes, etc. are addressed in a timely manner and that appropriate corrective and preventive actions are taken.- Determine quality metrics for the assigned area.- Assures that all personnel from the assigned area are trained and compliant with internal and external regulatory requirements. Assures appropriate training files are maintained.- Develops and manages the department budget and resources.- Drive continuous improvement in supplier performance through utilization tools such as DOE, Six Sigma, DMAIC, FMEA, SPC, 8D Root Cause Analysis, and Lean.- Respect of Ethics and Data Privacy requirements- Responsible to coordinate inspection and testing in Assembly product line- Managing CAPA related with assigned areaEDUCATION, EXPERIENCE AND QUALIFICATIONS:- A minimum of 3-8 years' experience in Quality Assurance or Regulatory Affairs, with medical device experience preferred