In this role, you will have the opportunity to:
* Represent the Ilfracombe site as the Quality Management Representative and lead management reviews
* Responsible for the leadership & development of the QA site function.
* Responsible for implementing the QMS
* Ensure QMS procedures, work instructions, and IT System effectively support the Ilfracombe site organization - Collaborate with Global QMS Subject Matter Experts (SME) as required.
* Support the Global QMS team on Global process and procedure changes and represent the needs of the site during change management and continuous improvement discussions.
* Accountable for setting & monitoring Quality KPI’s including, reporting on performance/ trend insights within business reviews.
* Ensure effective communication style with stakeholders and establish cross functional operating mechanisms, where appropriate to ensure Quality goals are met.
The essential requirements of the job include:
* Minimum, Bachelor's degree, preferably in a Science or Engineering discipline
* A minimum of 5 years working in Quality Assurance/Quality Engineering or Product Engineering -within Life Science, Medical Device or Biopharma manufacturing environments
* 2-4 years of supervisory experience
* Knowledge of ISO, FDA, cGMP’s, and CFR requirements
* Experience with Root Cause Analysis Tools, Lean Manufacturing, and Six Sigma.
* Knowledge of quality statistical methods and tools
* Experience supporting validation and technology transfer activities.