Program Manager, Global Quality

Program Manager – Pleasanton, CA, Burlington, CA, or Atlanta, GA

• Lead cross-functional teams to meet program objectives including scope, budget, and schedule
• Prepare and/or support detailed Quality Improvement Plans and other business plans
• Establish and prioritize project deliverables
• Author and review quality system procedures and work instructions
• Lead cross-functional teams to develop project timelines consistent with business strategy and expectations
• Support audits and present completed and planned development process improvements, as appropriate
• Identify and support implementation of harmonized software development tools
• Drive program execution per milestone commitments (project timeline)
• Ensure appropriate impacts, risks, mitigations are developed and communicated in the face of requested or required program commitment changes
• Prioritize program workstreams, consistent with business strategy
• Facilitate strong collaboration among cross-functional core team members
• Communicate with all levels of the organization the objectives, status, risks, and needs for the program
• Identify potential roadblocks early and lead the team to develop and implement counter measures
• Interface with appropriate internal and external resources (regulatory agencies, customers, etc.) to ensure development programs meet regulatory and customer requirements
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
• Maintain positive and cooperative communications with all levels of employees, customers, contractors, and vendors

• Bachelor’s degree in engineering
• 10+ years of experience in Quality, Engineering and/or R&D within a medical device/biomedical, high technology, and/or any other regulated industry
• Experience in software product development and process improvement
• Experience in applying FDA guidance for multiple function devices (regulated and not regulated as a medical device) and creating quality system(s) and associated infrastructure to support
• Experience collaborating with project stakeholders (client and internal), end-users, business partners, and technical team members for development of quality systems
• Strong verbal and written communication skills with ability to effectively communicate with multiple levels in the organization
• Previous experience working in a matrixed and geographically diverse business environment

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit
• 401k matching
• Health insurance
• Flight privileges

Abbott is a global healthcare leader that helps people live more fully at all stages of life