Engineering Protocols Change Control Reporting Organizational Change Management Engi   Requirement id 55520 Job title Engineer Job location in GREENWOOD VLG, CO Skills required Methodologies And Designs, Engineering, Protocols, Change Control Reporting Organizational Open Date 11-Aug-2016 Close Date Job type Contract Duration 9 Months Compensation DOE Status requirement --- Job interview type --- Apply    Email Recruiter: coolsoft Job Description Engineer: Methodologies And Designs, Engineering, Protocols, Change Control Reporting Organizational Start Date :08/01/2016 End Date :04/28/2017 Submission Deadline :08/17/2016 Description : This position is a contract position that will go from time of hire through April 2017. The primary responsibility for this Sr. Quality Engineer is to provide quality lead oversight representing the Voice of Quality for activities within assigned Process and Sustaining Engineering Value Stream project teams. This position will lead and manage validations, change control, and sustaining activities as requested to support the transfer of product lines to outsourced 3 party contract manufacturing sites. The Sr. Quality Engineer is responsible for providing quality oversight representing the Voice of Quality in assigned Process and Sustaining Engineering Value Stream project teams. Specifically, this position will participate and provide quality oversight and input for daily activities related to production support including non-conforming material and disposition activities, Corrective and Preventive (CAPA), and customer complaint analysis. This position will support Process Validation and validation reviews to create related validation documents including protocol development, execution, and results documents as a member of project teams supporting and performing Validation activities related to product line transfers. This position may also support New Product Development project teams, managing and performing V&V activities including protocol development, execution, and results reporting. The Sr. Quality Engineer is also responsible for providing technical support and quality leadership for the project team, manufacturing, distribution, engineering, and other functional groups. Organizational Chart/Reporting Relationship: Supervision Exercised: Technicians and others as required. The Sr. Engineer may provide training, work direction and problem solving assistance to less senior engineers and technicians. Supervision Received: Works under the general direction of the QE Lead or Manager. Direction is provided in the form of objectives, milestones and approach. Essential Functions: The Voice of Quality in Process Change and Improvement projects including daily production support. Engineering test management. Applies advanced knowledge and analytical skills to assignments of diverse scope and complexity. Leads teams within projects of moderate scope and complexity. Leader, trainer, coach and mentor within the Quality Organization and throughout the company. At this level, high expectations are placed on consensus building skills and integrating department objectives into personal objectives and work plans. Understanding of food and drug laws, regulations, and practices, and accurately transmit them into Baxter documents, programs, and behaviors to ensure that Baxter is at the forefront of regulatory compliance. Promotes high standards of reliability in product offerings. Probes beyond the stated issue for the underlying causes. Duties/Responsibilities to accomplish Essential Functions: Specific responsibilities may include, but are not limited to: Creates protocols, manages and performs V&V and process validation testing. Demonstrates commitment to project team results and assists other team members in meeting their goals. Contributes to project planning process. Adjusts to multiple demands and shifting priorities. Provides leadership and guidance in the area of process validation. Studies and interprets data, presents facts, and provides recommendations and judgment to influence decisions. Clearly explain assumptions, methodologies, and rationale. Effectively communicates complex inf   Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 55520 while calling.   Other jobs in CO: Denver (5), Fort Collins (1),    Methodologies And Designs job openings in other states Jobs List Business Analyst 5 -127984 Create date: 11-Mar-2024 Start date : 04/01/2024 End Date : 1 Years from projected start date Submission deadline : 3/15/2024 at 10am EST. Client Info : DHHS Note : * Interview Process: Virtual Interview via MS Teams video. Please use laptop and be prepared so share screen if asked. 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