Around the world, our employees are united by our mission to save and sustain lives. Together, we create a culture that encourages colleagues to pursue rewarding careers -- where everyone has the opportunity to do meaningful work as a part of a team they respect, in an environment that values each person’s contributions. We’re happy you’re interested in continuing your career journey with Baxter.

NCR and CAPA Process owner including facilitating the governance process for all quality records at the site. NCR investigation owner for quality, production and maintenance areas. Conducts reviews of documentation and reports for conformance to procedures, protocols, and regulatory requirements.  Provide Quality support with assigned projects and/or audits.

• Responsible for reviewing documents, records and reports against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal   guidelines, etc. 
• NCR/CAPA process owner including governance of quality records.  Nonconformance Investigation owner and quality approver.
• Performs initial investigative actions on post market complaints, applying well-established techniques and procedures.
• Create or revise standard procedures.
• May administer and maintain relevant databases.  Prepare and issue reports as defined as well as develop custom reports as needed.
• Qualified Internal Auditor
• Assist in external audits by maintaining audit records, extracting data from databases, and creating reports, collecting relevant data, etc. 

• Duties may require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate office equipment is required.
• Position requires standing and walking for extended periods of time. 

•  Working knowledge of medical products.
•  Excellent computer skills.
•  Knowledge of JDE.
•  Good communication, written and oral skills.
•  Knowledge of regulations outside United States a plus.
•  Self-motivated with the ability to work both collaboratively and independently.
•  Ability to drive decisions and actions.
•  Excellent organizational skills, problem solving skills, and attention to detail.
•  Ability to perform multiple tasks simultaneously and work cross-functionally in a highly-matrixed

   environment.

•  Expertise in interpreting regulations and familiarity with GDP and GMP.
•  Experience with working in an environment subject to compliance with 21 CFR Parts 7, 11, 803, 806,     810, 820 strongly preferred.

• Associates Degree in science or equivalent.
• 3-5 years’ experience in Quality with a medical device / Pharma company or other similarly regulated industry.

Equal Employment Opportunity

Baxter 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 Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.