Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
- Provide guidance to product development teams as to the required deliverables to ensure compliance throughout product development cycle.
- Review, assess and approve product design milestones and deliverables throughout product development cycle to ensure compliance.
- Assist Project Teams to identify compliance risks during the product development cycle.
- Review and approve DHF and DMR documents and other records for the Quality function, including V&V, Risk Management, etc.
- Educate and train and facilitate Project Teams on design control best practices by partnering with DCoE quality.
- Recommend, lead, and/or support projects for improvements to the quality system as approved by management.
- 8-10 years working experience and understanding of product development in a medical device environment or regulated industry
- Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
- Strong knowledge of FDA, ISO, and MDD regulations.
- Devises new approaches to complex problems through adaptations and modifications of standard technical principles
- Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
- Must be able to provide solutions that reflect understanding business objectives and cost implications.
- Effectively operate in and may facilitate cross-functional teams with minimal guidance.
- Ability to prioritize multiple tasks.
- Bachelor?s degree in Engineering
Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.
