Job Opportunity
We are seeking a highly skilled professional to fill the role of Change Management Specialist.
As a key member of our team, you will provide technical leadership and direction in changes to our quality management system.
You will be responsible for overseeing and ensuring that changes to quality management system processes and procedures are compliant, effective, and pose no risk to the quality of our products or processes.
This is a hybrid position with initially 3-4 days on-site and approximately 1-2 days remote work. You will work closely with the QMS team with moderate supervision and mentoring.
Main Responsibilities:
* Execute and/or participate in the Change Control review forums and 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 appropriateness.
* Liaise with Change Requester and SMEs during all stages of the Change Control process.
You will also have the opportunity to support and lead initiatives for continuous improvement and participate in cross-plant and corporate project teams in areas of change control.
Requirements:
* A Level 8 qualification or equivalent in Engineering, Science, or a relevant field.
* Previous experience in the medical device industry desirable.
* Understanding 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 projects.
* A good understanding of engineering and quality concepts/theories.
* High level of PC skills.
* Self-starter with an efficient work style and ability to handle multiple tasks in a fast-paced environment.