What you'll be doing
Define and execute the site Quality strategy, ensuring alignment with business objectives, regulatory requirements, and global quality standards.
Ensure effectiveness, compliance, and continuous improvement of the Quality Management System (QMS) across all processes.
Drive internal and external quality escalations, ensuring rapid containment, structured problem-solving, and effective communication with stakeholders, including leadership, customers, and regulatory bodies.
Utilize data trending and signal detection to proactively identify risks and drive systemic improvements.
Strengthening systems and processes to ensure audit readiness and sustained regulatory compliance.
Lead, mentor, and develop the Quality organization, fostering a culture of quality ownership, accountability, and continuous improvement.
Strengthen team capability in problem-solving, compliance, and quality systems execution.
Promote a culture aligned with patient safety, regulatory excellence, and ethical standards.
What you'll bring
Bachelor’s degree in engineering, Life Sciences, or a related technical discipline (Master’s preferred)
Minimum 7+ years of experience in Quality Assurance/Quality Engineering in a regulated industry (medical device preferred).
3+ years in leadership or supervisory roles within QA/QC functions.
Strong working knowledge of FDA 21 CFR Part 820/11 and ISO 13485 requirements.
Join us now!
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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.
Reasonable Accommodations
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