Quality Assurance Specialist
hace 1 mes
Transforming Healthcare through Quality Excellence
Baxter is a leading medical device company dedicated to improving patient outcomes through innovative products and therapies. We are seeking a highly skilled Quality Assurance Specialist to join our team.
Key Responsibilities:
- Ensure compliance with QSR part 820, ISO-13485, and other applicable regulations.
- Implement, monitor, improve, and report on metrics to monitor Quality performance.
- Lead/oversee validation activities, IQs, TMVs, OQs, PQs, for designated areas.
- Ensure that the validated status is maintained during any decision-making process.
- Lead or participate in NCR, SNCR, CAPA activities in accordance with established procedures and ensures compliance with quality objectives.
- Assist 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.
- 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.
Requirements:
- Excellent 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.
- 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.
- Green Belt Six Sigma.
About Baxter:
Baxter is a global leader in medical devices and therapies. Our 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.
Why Join Us:
At Baxter, you'll have the opportunity to work with a talented team of professionals who share your passion for improving patient outcomes. You'll have the chance to develop your skills and expertise in a dynamic and supportive environment. Join us and be part of a team that is dedicated to making a difference in people's lives.
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