Regulatory Compliance Specialist

1 day ago


Minneapolis, Minnesota, United States Baxter Healthcare Corporation Full time
Advancing Patient Care through Quality Engineering
Baxter is committed to advancing patient care through innovative solutions and collaborative approaches. As a Principal Engineer, you will contribute to the development and maintenance of Peritoneal Dialysis (PD) disposable products, ensuring they meet the highest quality standards. With a strong background in Quality Engineering, you will provide guidance to project teams, applying Quality Engineering principles to develop robust, safe, and effective products.

About the Team
The Renal Peritoneal Dialysis (PD) Product Quality Engineering Team is a dynamic group of professionals dedicated to delivering high-quality products. Your role will involve collaborating with team members to ensure successful design, testing, and transfer of medical products. You will also work closely with external partners and corporate groups to transfer new and improved products, leveraging your knowledge of global Regulatory and Quality requirements for medical devices.

Responsibilities
• Provide quality oversight and mentorship to project teams
• Develop and review documentation related to product development
• Ensure compliance with applicable regulations and policies
• Collaborate with external partners and corporate groups to transfer new and improved products

Requirements
To succeed in this role, you will need:
• A Bachelor's degree in Engineering (Biomedical, Mechanical, or Electrical preferred)
• At least 8 years of experience in Quality, Engineering, or Manufacturing
• Relevant experience supporting products in a regulated environment
• Strong problem-solving and analytical skills, with excellent communication and interpersonal abilities

Estimated Salary
The estimated salary for this position is $104,000 to $143,000 annually, based on location, skills, and expertise.

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