Lead cross-functional teams to meet program objectives including scope, budget, and schedule.
Core responsibilities include.
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.
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 (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.
Benefits
Career development with an international company where you can grow the career you dream of.
Employees can qualify for 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 - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
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 toolsproject timelinesprocess improvementsFDA regulationsquality systemssoftware product developmentengineeringR&D