Key responsibilities:
* Design, develop, and optimize manufacturing processes for transfer project.
* Conduct process validations and ensure compliance with FDA and ISO regulations.
* Draft and execute IQ, OQ, PQ in cleanroom environement
* Collaborate with product development teams to ensure manufacturability of new products.
* Monitor and analyse process performance metrics to identify areas for improvement.
* Implement Lean and Six Sigma methodologies to drive continuous improvement initiatives.
* Troubleshoot process issues and work collaboratively to develop effective solutions.
* Prepare technical documentation, including process flows, standard operating procedures (SOPs), and process validations.
* Establish Process Monitoring and Control.
* Train and support manufacturing personnel in new processes and technologies.
* Participate in risk management activities related to process development and implementation.
* Conduct root cause analysis and implement corrective actions for process deviations.
Your Profile
Essential skills/knowledge/experience:
* Strong understanding of manufacturing processes in MedTech industry, including injection moulding, CNC, assembly, and sterilization.
* Knowledge of quality management systems and regulatory requirements (e.g., FDA, ISO 13485).
* Proficiency in statistical analysis and process improvement methodologies, such as Lean and Six Sigma.
* Ability to interpret engineering drawings and technical specifications.
* Excellent problem-solving skills and analytical thinking.
* Effective communication skills with the ability to work in cross-functional teams.
* Proven track record of successfully implementing process improvements and optimization.
* Experience with process validation and regulatory compliance in a MedTech environment.
* Familiarity with project management principles and experience leading cross-functional projects.