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.Provides Quality oversight/guidance for business unit product lines and quality systems. Able to combine input from multiple sources to provide solutions to teams and manufacturing facilities regarding product quality, design, and regulatory compliance. Key participant in change management and provides guidance for new product development and existing products and processes. Effectively interfaces with all functions to achieve project success in a team setting. Leads projects for improvements to the quality system. Periodically reviews the suitability and effectiveness of the quality system with executive management.
- Analyzes data from various sources (including, but not limited to: Non-Conformances, FCA, MDR, Complaints, etc) to drive decision-making and effective corrective/preventive actions.
- Provides quality engineering guidance to product development teams throughout the product development process (PDP) to ensure compliance to the required PDP deliverables, resulting in the development of safe and effective medical devices.
- Plans and leads the analysis, test, verification, inspection, and integration of design to ensure the quality of components and/or products.
- Assists project teams to identify compliance risks during the product development cycle.
- Communicates significant issues or developments identified during quality assurance activities and provides recommended improvements.
- Prepares and presents technical and PDP program information to team members and management.
- Educates, trains, and facilitates project teams on design control best practices by partnering with DCoE quality.
- Utilizes Design for Six Sigma (DFSS) tools to promote a disciplined approach to product and process design in order to ensure product quality and process capabilities.
- Participates in corrective and preventive actions (CAPA)-related activities, including CAPA ownership if appropriate.
- Recommends, leads, and/or supports projects for improvements to the quality system.
- Reviews and approves work for inclusion in Medical Device Reports (MDR?s) and provides leadership in the management of investigations supporting an MDR.
- May supervise one or more engineers or technicians.
- B.S. degree in Engineering (minimum requirement) and 9-13 years of experience in Product Development, Manufacturing, or Quality.
- ASQ Certified Quality Engineer or equivalent experience. Able to certify within one year.
- Completely proficient in product & process development concepts, including change control and risk management.
- Extensive cross-functional team experience, including technical and non-technical work.
- Ability to organize and present technical and project management overviews without assistance.
- Demonstrated ability to work independently.
- Working knowledge of 21CFR820 (quality systems regulation/good manufacturing practices for medical devices) ISO 13485:2003, and ISO 14971 (risk management).
- Problem Solving ? Apply DMAIC and statistical techniques to address issues and investigations. Resourceful and independent. Applies organizational and technical knowledge to move teams through issues.
- Recognized for technical expertise by peers and or other personnel within the business unit.
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.
