Our client a leading medical device company based in Cork, Ireland is recruiting for an experienced Project Manager to join their team.
The Project Manager will be working with transferring and implementing processes either from development or from another manufacturing facility.
- Project planning, in detail, in support of major project, product/process transfer etc.
- Ensure regulatory compliance to GMP’s of all medical device regulatory agencies (e.g., FDA, ISO, and MDD).
- Liaise with product support teams, R&D and regulatory on component quality issues and supplier initiatives.
- Liaise with quality and engineering both internal to the plant and externally within the corporation.
- Drive new supplier qualification and suppler quality initiatives when required.
- Liaise directly with vendors under the control of Quality / Logistics. This involves travel to supplier sites so this person must be available to travel at short notice.
- Development and implementation of appropriate supporting documentation, which complies with GMP in conjunction with the other team members.
- Responsible for other projects as assigned by the company.
- Deliver project status updates to senior management and project sponsors incorporating status reports and project plan updates.
- Establish and support a work environment of continuous improvement that supports the company’s Quality Policy, Quality System and the appropriate regulations for the area they support.
- Ensure employees are trained to do their work and their training is documented.
- Development of and adherence to project contract (IBP).
- Development of Operations launch strategy.
- Liaise with Core Team Leader, other team members and functional management as necessary.
- Lead resolution of problems that impede project progress.
- Identify and escalate unresolved obstacles to the success of the project.
- Provide leadership, standardization and implementation of best practice for project management on site.
Experience, Education and Skills:
- Level 8 qualification or Masters in relevant engineering discipline.
- 3 + years of managing New Product introduction for Medical device or within a regulated environment.
- Ideally PMP or IMPA certified.
- Demonstrated ability to manage and deliver key projects in a timely manner.
- Experience of managing & co-ordinating resources.
- Experience of budget allocation for projects.
- Excellent Communication & Organisation Skills.
- Ability to influence with all stakeholders both internally and externally.
For further information on this Project Manager role in Cork please contact Caroline Kingston on 0868395531/ email@example.com
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