Internal Audit & Regulatory Analyst
Posted on: May 13, 2022
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. -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
- 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
- Use of electronic audit tracking systems.
- Communication with regulatory agencies, including external
- Ensures timely communication of significant GMP and or product
quality issues to management.
- Ensures timely completion of all Quality System
- 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
- 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
- Use of hands and fingers to manipulate office equipment is
- 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
- 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
- B.S. degree in science, engineering, or related
- 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. - - - - - - - - - - - - - - - - - - - - - - - - - -
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- - - - - - - - - - - - - - - - - - - - -Reasonable
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 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 .
Keywords: BAXTER, Columbus , Internal Audit & Regulatory Analyst, Professions , Cusseta, Georgia
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