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Internal Audit & Regulatory Analyst

Company: BAXTER
Location: Cusseta
Posted on: May 14, 2022

Job Description:

This is where you save and sustain livesAt 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.Summary:This role is responsible to establish and maintain an effective internal audit system to ensure the QMS complies with established QMS requirements and to determine its effectiveness. Additional responsibility includes regulatory liaison for the site, including but not limited to, registration, submissions, external audit response, and licensing renewal.Internal Quality Audits. Internal Quality Audits are used to determine the effectiveness of the implementation and maintenance of the Baxter Quality Management System (QMS) and its conformance to standards and regulations as directed by the Baxter Corporate Quality Manual.Regulatory. Medical devices are regulated with the aim to ensure the safety and effectiveness of the device. Regulatory guidance relates to the products manufactured, the applicable submissions, and countries of registration.Essential Duties and Responsibilities:

  • Manages the internal quality audit process to ensure audits are conducted when required by qualified individuals, corrective action is taken where necessary, audit results are documented and reported appropriately.
  • Creation and issuance of an annual audit schedule, based on risk, compliance history, and QMS complexity.
  • Development of audit strategy, scope, audit team, schedule, opening, and closing presentations.
  • Ability to perform risk-based assessment and rank observations for critical, major, and minor.
  • Qualification in and maintaining of auditor qualifications with retention of the associated documentation.
  • Ensures the established internal audit procedures are compliant, effective, and sustainable.
  • Ensures all audit records (hard copy and electronic) are appropriately identified, and stored in a controlled and secure manner, and are retrievable in a compliant, efficient and timely
  • Use of electronic audit tracking systems.
  • Communication with regulatory agencies, including external audit responses.
  • Ensures timely communication of significant GMP and or product quality issues to management.
  • Ensures timely completion of all Quality System commitments.
  • Proactively identify and support the implementation of continuous improvement opportunities in quality areas.
  • Provides additional support in quality areas as needed while maintaining compliance with current good manufacturing practices (GMPs), environmental health and safety (EHS) guidelines, and any other regulations that could apply.General Expectations:Quality: Ensure the quality of our products to ensure patient safety and achieve our mission of "Saving and Sustaining Lives". This can be achieved through:
    • Following Good Manufacturing Practices (GMP).
    • Adhering to all quality procedures.
    • Completing training on time.
    • Doing it Right the First Time
    • Reporting any quality concerns immediately.Physical Requirements:
      • Use of hands and fingers to manipulate office equipment is required.
      • Position requires sitting for extended periods of time.
      • Duties may require overtime work.Skill Requirements:
        • Extensive knowledge of relevant FDA, Health Canada, MDSAP, and other international regulatory QMS requirements.
        • Demonstrated knowledge of current regulatory interpretations of QMS requirements and current industry best practices.
        • Ability to perform multiple tasks simultaneously, work cross-functionally and handle changing priorities and deadlines.
        • Ability to work independently.
        • Proficient in computer system use, including but not limited to Microsoft Office and QMS software.
        • Excellent written and communication skills.
        • Ability to drive decisions and actions.
        • Good interpersonal/influencing/negotiation skills.
        • Good project management skills.Education and/or years of experience:
          • B.S. degree in science, engineering, or related discipline.
          • 5+ years experience in Quality, Manufacturing, Engineering, or related field which should include 2 years of auditing experience at a minimum.Preferred:
            • ISO Auditor/Lead Auditor certification
            • Working knowledge of ISO-13485 Medical Products industry and US/EU (MDR) regulations.
            • Trackwise experience preferred.#LI-AD
              #IN-USOPSThe 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 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.Recruitment Fraud Notice

              Baxter 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.058955

Keywords: BAXTER, Columbus , Internal Audit & Regulatory Analyst, Professions , Cusseta, Georgia

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