Change Management Specialist (CAII)
Contract: 18 Month Contract
Hybrid Position: Initially 3-4 days On-Site, and approx. 1-2 Days afterwards
Location: Supporting both Limerick & Tullagreen, Carrigtwohill Site. Preference would be Limerick based however, open to either.
The Change Control Analyst will provide technical leadership and direction in changes. Responsible for the oversight & assessment of changes to the quality management system. Will oversee and ensure that changes to quality management system processes and procedures are compliant, effective and pose no risk to the quality of the product/processes. Will work within the QMS team, with moderate supervision and mentoring, with responsibility for quality related activities, including, but not limited to the following:
Main Responsibilities:
Execute and/or Participate in the Change Control review forums and in multi-site forums.Lead, facilitate, and mentor teams through all stages of the change control process.Interface between functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes.Have responsibility for initiation of changes, assessment of the change impact and routing of all tasks, with attention to detail, for completeness, accuracy, effectivity and appropriatenessLiaise with Change Requester and SMEs during all stages of the Change Control process.Reviews all changes for ensuring sound rationale, challenging justification, correct approval, alignment and oversight.Monitoring completion of post release tasks to ensure completion in a timely manner.Support and lead initiatives for continuous improvement.Participate in cross-plant and corporate project teams in areas of change control.Manage Change Control KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums.Support in training needs related to the change control processSupport in the preparation, participate and follow up to Stryker Internal, Corporate and third-party compliance audits.Experience & Skills Required:
Level 8 qualification or equivalent in Engineering, Science or relevant fieldPrevious experience in the medical device industry desirableUnderstanding of Med Device concepts desirable.Familiarity with ISO 13485, GDP, GMP concept desirable.Excellent communication skills and attention to detail.Knowledge of ERP Change Control Systems.Experience working cross-functionally across projectsHave a good understanding of engineering and quality concepts / theories.High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.Must be willing to work as part of a multi-site team, with some travel required.Knowledge of Risk Based and statistical concepts desirable.Problem solving and analytical skills.Builds strong relationships by fostering open communications, respect and trust#IJ
Travel Percentage: None