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Sr. Quality Engineer (CAPA)

Req #: 180002CP_en
Location: Irvine, CA US
Job Category: Engineering
Date Posted: 1/30/2018 5:29:48 PM
Baxter International


Responsible for Corrective Action and Preventive Action (CAPA) implementation as well as Non-Conformance (NC) investigations and process activities.

Effectively leads and serves as a mentor to others to ensure the NCR/CAPA Process is adequately followed.


     Ensure compliance to the NCR process requirements and the consistency/quality of CAPAs and NCRs.

     Responsible for assigned NCR/CAPA records.

     Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving non-conformances.

     Provides project direction, coaching, and mentoring for CAPA teams as required.

     Drive timely execution of CAPAs and NCRs deliverables through monitoring and reporting status to CAPA and NCR owners.

     Leads CAPA Review Board and CAPA Governance meetings.

     Leads NCR/CAPA tier meetings to ensure timely execution.

     Interface with management and peers to assess and improve the adequacy of the processes. This includes but is not limited to the remediation of CAPA and NC deficiencies noted in audits and/or inspections.

     Provide support/responses during audits/inspections relating to the CAPA and NCR systems as required.

     Effective CAPA and NCR data analysis and trending.

            Provide NCR/CAPA training.

     Quality data metrics analysis, trending and reporting.

    Support Doc Center activities for document processing, batch release and training.

               Escalates issues to supervisor/manager for resolution, as deemed necessary.




BS in Engineering. 1 - 3 years’ experience


Qualifications include:
•Working knowledge of ISO 13485, FDA 21 CFR Part 820 (specifically 820.100).
•Working knowledge of NCR/CAPA systems.
•Solid analytical and problem solving skills.
•Strong project management and organizational skills.
•Excellent attention to detail, resourceful, self-reliant, self-motivated and confident.
• Knowledge of root cause analysis tools such as: 8D, 5 Whys, Fishbone, DMAIC
• Knowledge of Six Sigma and statistical tools for data analysis
• ASQ CQA, CQPA certification

• Understanding of risk management process



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
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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.

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