Quality Project Manager - 30424

Develop and manage project objectives, strategies, timelines and milestones for Quality related initiatives. Translate project goals into project tasks. Identify resource requirements, costs, time schedules and need to develop relationships with contractors, vendors and/or consultants. Develop an implementation plan, conducts risk assessments and develops contingency plans to accommodate unforeseen events. Manage the Management Review process. Identify gaps in Quality Processes and manage the development and implementation of improvements. Must have a 4-yr degree in Engineering, Science or related area or possess equivalent, relevant experience. Relevent experience would consist of 6-10 years relevant Quality-related experience in medical device, diagnostics or pharmaceutical manufacturing. Six Sigma Black Belt, American Society of Quality (ASQ), or Project Management (PMP) certification is preferred.

The Project Manager will work with the project team technical leader to establish and execute development plans for medical device software. The Project Manager will lead the team on defining the product design control strategy as well as the overall scope, timeline and budget of the project. Once a plan is in place, the Project Manager will drive for results and ensuring team focuses on project objectives.

Translate project goals into project tasks. Identify resource requirements, costs, time schedules and need to develop relationships with contractors, vendors and/or consultants. Develop an implementation plan, conducts risk assessments and develops contingency plans to accommodate unforeseen events.

Position Accountability:
Accountable for driving product development design control from initiation through design transfer including the planning and interactions across R&D, Manufacturing, and Quality/Regulatory
Assure that Design Control and compliance requirements are met.
Accountable for the successful completion of project tasks on time and within budget.

Must have a 4-yr degree in Engineering, Science or related area or possess equivalent, relevant experience. Relevent experience would consist of 6-10 years relevant Quality-related experience in medical device, diagnostics or pharmaceutical manufacturing.
Demonstrated success in navigating a full software project life cycle
PMI certification desired
MS Project, Visio
Familiar with programming languages, such as C++, Java, C#.
Familiar with platforms such as J2EE, Web Services
Working knowledge of current Internet technologies.