Project Manager Jobs in Indiana

Job Title: Senior Quality Project Manager - Order Fullfilment Company: Baxter HealthCare Location: Bloomington, IN Description: Job details Req ID 39161BR Business Title Senior Quality Project Manager - Order Fullfilment Business Global Quality Sub-Business MD-GIS Support Country United States State/Province Illinois Location of Position Round Lake, IL Shift_ 1st Job Description Provides Quality ownership for business quality systems. Able to combine input from multiple sources to provide solutions to teams and manufacturing facilities regarding quality system structure, execution, and regulatory compliance. Key participant in change management and leads development improvements to quality system processes. Effectively interfaces with all functions to achieve project success in a team setting. Periodically reviews the suitability and effectiveness of the quality system with executive management Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. 1. 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. Establishes processes for analysis of quality systems. Ensures the appropriate process metrics are defined and agreed upon Gathers feedback from users and data on execution of quality system elements. Stays abreast of current expectations within the industry and from regulatory bodies Utilizes results to prioritize process improvement efforts. Prepares and issue reports based on information analysis. Escalates issues detected to CAPA process. 2. Work with other process owners to determine significant issues related to system interfaces. Lead improvement efforts on owned systems. Support improvement efforts on other systems. 3. Help the training team with training design and ongoing refresh of requirements 4. Prepares and presents quality system and business process information to team members and management. 5. Participates in corrective and preventive actions (CAPA)-related activities, including CAPA ownership for system related issues. 6. Identifies complex problems and leads cross functional projects for improvements to the quality system. Independently plan, execute and direct cross functional quality system improvement programs Develops creative approaches to quality system design and execution through use of advanced problem solving methodologies. 7. May supervise one or more engineers or technicians. Job Requirements Bachelors degree in Engineering (minimum requirement) and 9-13 years of experience in medical device or other regulated environments is required. 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. Strong 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. Percent Travel Required 10% Index Monitor