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.
What you'll be doingEnsure compliance with QSR part 820, ISO-13485 and other applicable regulations.
Implements, monitors, improves and reports on metrics to monitor Quality performance.
Ensure that the non-conforming material process is executed in accordance with established procedures and in compliance with determined metrics.
Leads/oversees validation activities, IQs, TMVs, OQs, PQs, for designated areas.
Ensures that the validated status is maintained during any decision-making process.
Leads or participates in NCR, SNCR, CAPA activities in accordance with established procedures and ensures compliance with quality objectives.
Assists management and departmental staff in the implementation of statistical quality control techniques in order to improve operational efficiency and effectiveness.
Responsible for the analysis of data obtained from the field to investigate and resolve issues identified through Post Market Surveillance Report.
Participates or leads project transfer, through the identification and closing of gaps from the quality system and manufacturing processes, establishing product acceptance criteria, ensuring quality controls and supporting project deadlines.
Participate in Value Stream projects (quality improvements, cost savings, productivity gains).
Ensure that all inspection and test specifications are properly performed and documented.
Conduct a root cause analysis to prevent recurrence.
Supervise that all personnel reporting to him/her are adequately trained for the functions they perform.
Conduct routinary internal audits, Gembas, LTTs of the quality system in compliance with procedures.
Reports audit results to management.
Supervise and coordinate the function of the Quality Technicians, Quality Intern and Quality Eng C.
Ensures compliance with assigned KPIs and notifies management of any possible impact.
Ensures that subordinates' duties and responsibilities are clearly defined and that performance is routinely measured and reviewed.
Creates and establishes development plans to build high performing teams.
Supports analysis, investigation and field actions.
Creates consignees list and contacts clients to obtain required information.
Creates, monitors and ensures compliance with quality plans.
What you'll bringExcellent verbal and written communication skills (English/Spanish).
Bachelor's degree.
Personnel Management.
Training - Knowledge on risk management ISO 14971.
QSR Part 820 Training / Awareness and ISO13485.
Root cause Analysis.
Formal education or training in quality control techniques, including quality system audits, statistical tools, design of experiments, statistical sampling methods and testing methods, Lean principles, etc.
(Deseable).
Desired Knowledge in medical device regulations and standards, including FDA medical device regulations covered by Title 21 CFR Part 820, European Medical Device Directive 93/42/EEC / EU MDR.
Quality Eng certified by ASQ (Deseable).
Green Belt Six Sigma Certified (Deseable).
Five years in similar positions.
Problem Solving.
Focused on Results.
Validation Experience (IQ, TMVs OQ, PQ).
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