This is a 23 month fixed term contract role based in Carrigtwohill. The position focuses on quality assurance, control and preventative activities with an emphasis on continuous improvement of internal products and processes.
Key Responsibilities:
* Support supplier quality issues impacting daily operations
* Advocate and lead the execution of initiatives to enhance quality performance within the business and for our customers
* Mentor and provide technical direction across multiple areas of expertise
* Ensure compliance to regulation and standards
* Manage multiple tasks simultaneously
Requirements:
* BS in a science, engineering or related discipline
* Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired
* Understanding of US and International Medical Device Regulations
* Familiarity with ISO 13485, GDP, GMP required
* Strong knowledge of Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics)
* Strong communication, project management and influencing skills
Benefits:
* Opportunity to work closely with operations and business functions
* Collaboration with cross functional teams to address top quality issues
* Chance to develop and improve internal manufacturing processes
About this Role:
This role is ideal for someone who wants to make a meaningful impact on the quality of our products and services. You will have the opportunity to work closely with various stakeholders and contribute to the development and implementation of quality initiatives.