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For your reference, we have included the original job posting below.
Specialist Device Quality Systems
Job Number:
42490052
Company Name:
Amgen
Job Location:
Longmont, CA US
Job Categories:
Engineering & Architecture Manufacturing & Production
Specialist Device Quality Systems
Under minimal direction, position will be responsible for managing Device Quality System business processes driving implementation of SOPs and Operating Standards that support the Device Business Process and in accordance with applicable global standards.
Successfully communicate with all levels of the organization and facilitate development of device quality systems.
Act as a Subject Matter Expert for Device Quality Systems, programs, and procedures. Provide daily oversight, guidance, and support in regards to the Device Quality Systems.
Tasks:
Own, review and approve SOP's.
Review and approve change control records.
Initiate and own change control records as needed.
Lead and participate in projects as needed.
Participate in global Quality initiatives ensuring Amgen Device Quality input is provided and leading lead implementation activities.
Act as owner for Device quality programs and procedures
Other tasks may be assigned
Basic Qualifications • Doctorate degree OR • Master's degree & 3 years of directly related experience OR • Bachelor's degree & 5 years of directly related experience OR • Associate's degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience
Preferred Qualifications Experience in project management, process improvement, or performance management consulting
Demonstrated ability to navigate through ambiguity and provide a structured problem solving approach
Organizational savvy and presence to build effective relationships across functions
Track record of building or participating as a member of high performing teams
Proficiency in MS Office tools including Excel, PowerPoint, Word, MS Project and Visio
