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This is where you will be resilient as you lead our Cartago, Costa Rica plant quality team and strive to create the best possible product for our patients. You will make an impact on patients by ensuring systems, processes, and procedures for regulatory compliance are established and deployed while serving as the Management Representative for the plant. You will strategize to ensure the measurable quality objectives and goals are met and communicated.
Job Responsibility:
Responsible for the outgoing, safety, quality, and efficacy of all finished products manufactured at the site
ensuring the quality system processes are effectively established and maintained in accordance with applicable regulations, standards, and Baxter Quality System requirements
ensuring and maintaining the GMP compliance status for their sites, per the applicable regulations and relevant GMP activities
responsible for establishing and maintaining an environment that encourages partnership and collaboration
coaching, training, and developing the quality team (50+ indirect reports).
Requirements:
BS degree in Science or Engineering required
10+ years related work experience in Quality, Manufacturing, or related field in a Medical Device/Pharmaceutical Industry
7+ years of management-level experience
ability to handle multiple projects concurrently
computer experience
knowledge of local regulations and application of Good Manufacturing Practices (GMP).
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