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About Baxter:
Baxter is a global leader in medical innovation, dedicated to saving and sustaining lives. Our mission is to improve healthcare outcomes for millions of patients worldwide.
Your Role at Baxter:
As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our medical devices. You will be responsible for developing and implementing quality and regulatory strategies, overseeing product development compliance, and driving continuous improvement in supplier performance.
Key Responsibilities:
- Develop and implement quality and regulatory strategies for the site.
- Oversee product development compliance for medical devices area. Respond to regulatory issues concerning products and business processes.
- Participate in special projects and initiatives, as requested.
- Review and assure that any noncompliance associated with manufacturing processes, audit findings, complaints, design processes, etc. are addressed in a timely manner and that appropriate corrective and preventive actions are taken.
- Assure quality metrics for the assigned area (RTY/FPY/NCMRS).
- Drive continuous improvement in supplier performance through utilization tools such as DMAIC, FMEA, SPC, 8D Root Cause Analysis, and Lean.
- Respect of Ethics and Data Privacy requirements.
- Responsible to coordinate inspection and testing in production lines.
Requirements:
- Bachelor's degree in Engineering Science.
- A minimum of 2 years' experience in Quality Assurance or Regulatory Affairs, with medical device experience preferred.
- Proven experience in driving continuous improvement in product performance through utilization tools such as DMAIC, FMEA, SPC, 8D Root Cause Analysis, and Lean.
- English intermediate.
- Visa up to date.
- Work with Assembly environment preferable.
