Our client a medical device company in Galway is looking to hire a Quality Systems Program Manager ona contractual basis for 6 month.
In this exciting role as a Program Manager in the CVG Supplier Quality Group you 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. You will have responsibility for review status of projects and budgets; management of schedules and preparation of status reports. Job responsibilities will focus on tactical needs for complex, on-going programs and accomplish results through matrixed teams. Collaboration with cross-functional resources to establish program objectives, timelines, and milestones will be key.
Responsibilities may include the following and other duties may be assigned.
- Functional Leader to build cross functional project planning and deliverables definition for projects. Lead Supplier and Purchasing Controls project management activities / continuous improvement projects (e.g. project planning, tracking, risk management and communications with project core team leaders) 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. Keep Core Team Leader, Project Review Committee, key Sponsors and Stakeholders abreast of organizational capacity constraints and portfolio risks.
- Operate as a role model by striving for continuous improvement and being an agent of change.
- 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.
- Review the initial drafts of strategy documentation prior to review with Stakeholders.
- May coordinate with enterprise cross functional project teams.
- Ensure Quality of all program and project outcomes, deliverables and products
- Comply with all Corporate policies, Standards, Procedures and Processes
- Determines and pursues courses of action necessary to obtain desired results
- Liaison: Frequent interaction with internal or external contacts at various organizational.
Must Have: Minimum Requirements
- Bachelor’s degree and 7+ years (or Master’s and 5+ years) of experience in quality, operations, or medical devices with 3+ years of sourcing/supplier quality experience plus 5+ years of progressive leadership experience in functional area.
- 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.
- Must be professional, dedicated, and detail-oriented. Other key qualifications include knowledge of and experience with domestic / International submissions; design controls systems and/or regulatory compliance or regulatory operations.
- Requires the ability to negotiate and manage competing priorities across multiple functional areas.
- Experience with FDA requirements, ISO 13485 and Medical Device Directive or other regulatory requirements is an advantage.
- Experience with personal computer office software
For further information on this Quality Systems Program Manager role please contact Clara Burke on 086 8168273/ firstname.lastname@example.org
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.