Program Manager – Quality Systems
What you need to know
Do you want to work for a leading innovative Medical Device Company in the West? Continue to read if so…
You will work as a Program Manager for our client in Parkmore, Galway. In this role you will work within the Cardiac and Vascular Supplier Quality Group and will have responsibility to oversee and manage the operational aspects of one or more large programs, or long-term projects. The role will require you to serve as a liaison between project teams and resolve issues by establishing priorities and reaching compromise with team members and functional managers.
The company is a leading organisation in their field.
This is an initial 6-month contract role.
Your new job
Key duties & responsibilities include:
- Build and lead cross functional project planning and deliverables for projects.
- Responsibility for review status of projects and budgets; management of schedules and preparation of status reports.
- Collaboration with cross-functional resources to establish program objectives, timelines, and milestones is key.
- Lead Supplier and Purchasing Controls project management activities / continuous improvement projects and collaborate with team members representing the functions of Sourcing, Manufacturing Engineering, Operations, Finance, Quality and Regulatory as necessary.
- Develop effective project goals, work breakdown structures, responsibility matrices of the Supplier and Purchasing Control projects and schedules and interacts with project team members to drive completion of project objectives.
- Identify costs and resource requirements for each program.
- Manage changing priorities on projects through effective schedule management
- Maintain best practices for developing and implementing Supply Management processes.
- Maintain current knowledge to ensure compliance to the FDA Quality System Regulations, European Requirements, and other regulatory requirements.
- Mentor & train employees related to systems, change control and the documentation for Supplier and Purchasing Controls Management.
- Ensure Quality of all program and project outcomes, deliverables and product
- Comply with all Corporate policies, Standards, Procedures and Processes
What are we looking for?
- Relevant Bachelor’s degree and 7+ years (or Master’s and 5+ years) of experience in quality, operations, or medical devices
- Experience with FDA requirements, ISO 13485 and Medical Device Directive or other regulatory requirements is an advantage.
- Demonstrated capacity for strategic thinking, project planning and project management.
- Strong communication, organizational, presentation and leadership skills are desirable. Good communicator and fluent in English, both in writing and speaking.
- Excellent analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions
- Excellent organizational and time management skills required.
- Successful track record of leading projects through implementation
- Strong computer skills, including MS Office Suite and database and project management software.
- Knowledge of and experience with domestic / International submissions; design controls systems and/or regulatory compliance or regulatory operations.
- Ability to negotiate and manage competing priorities across multiple functional areas.
Apply for this job now or get in touch with Aoife at firstname.lastname@example.org