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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Improvement Plansquality system proceduressoftware development toolsprocess improvementFDA guidancequality systemsproject timelinesprogram executionrisk managementregulatory compliance