Hybrid Program Manager – Global Quality

Posted 2 months ago

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About the role

  • Program Manager leading cross-functional teams in software quality system improvements for Abbott's Heart Failure division. Focusing on the design and development quality system with software integration.

Responsibilities

  • 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
  • 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

Requirements

  • 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 and creating quality system(s)
  • 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

Benefits

  • Career development with an international company
  • Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
  • Excellent retirement savings plan with a high employer contribution
  • Tuition reimbursement
  • Freedom 2 Save student debt program
  • FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree

Job title

Program Manager – Global Quality

Job type

Experience level

SeniorLead

Salary

$127,300 - $254,700 per year

Degree requirement

Bachelor's Degree

Location requirements

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