Manufacturing Process Specialist
We are seeking a skilled professional to join our global organization based in South Dublin.
* Process Development and Optimization: Develop and maintain manufacturing processes for medical device production, ensuring compliance with regulatory standards.
* Risk Management and Quality Control: Conduct risk analysis and implement corrective actions for process-related issues.
* Cross-Functional Collaboration: Collaborate with cross-functional teams (Quality, R&D, Operations) to support new product introductions and ensure compliance with ISO 13485, FDA, and other relevant regulatory requirements.
Requirements and Qualifications:
* Bachelor's degree in Engineering (Mechanical, Manufacturing, Biomedical, or related field).
* 4+ years of experience in a regulated manufacturing environment (medical devices preferred).
* Strong knowledge of process validation, risk analysis, and regulatory compliance.
* Proficiency in Lean/Six Sigma tools and methodologies.
About Our Organization:
We value corporate responsibility, sustainability, and diversity. We commit to building an inclusive workplace rich in diverse people, talents, and ideas.