Overview
- Develop and manage project objectives, strategies, timelines and milestones for Quality related initiatives. Translate project goals into project tasks. Identify resource requirements, costs, and time schedules. Develop relationships with contractors, vendors and/or consultants. Develop an implementation plan, conduct risk assessments and develop contingency plans to accommodate unforeseen events. Manage the Management Review process. Identify gaps in Quality Processes and manage the development and implementation of improvements.
- Collaborate with the project team and technical leader to establish and execute development plans for medical device software. Lead the team in defining the product design control strategy as well as the overall scope, timeline and budget of the project. Drive for results and ensure the team remains focused on project objectives.
- Translate project goals into actionable project tasks. Identify resources, costs, schedules and relationships with contractors, vendors and/or consultants. Develop implementation plans, conduct risk assessments and contingency plans as needed.
- Position Accountability: accountable for driving product development design control from initiation through design transfer, including planning and interactions across R&D, Manufacturing, and Quality/Regulatory. Ensure that Design Control and compliance requirements are met. Ensure the successful completion of project tasks on time and within budget.
Qualifications
Must have a 4-year degree in Engineering, Science or related area or possess equivalent, relevant experience. Relevant experience would consist of 6-10 years 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.
#J-18808-Ljbffr
