Internal Audit & Regulatory Analyst
Posted on: May 14, 2022
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
- 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.
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
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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