Description:
About Your New Employer:
- Join a company dedicated to developing cutting-edge medical devices that improve patient outcomes.
- GMP environment that adheres to standards such as ISO 13485, FDA 21 CFR Part 820, and EU Medical Device Regulation (MDR).
- Be part of a supportive team that values continuous improvement and professional growth.
About Your New Job as a Manufacturing Technician:
- Provide day-to-day technical support to the manufacturing line to ensure consistent and efficient operations.
- Respond promptly to manufacturing line stoppages or anomalies, troubleshoot and resolve issues related to equipment, tooling, process, or material.
- Perform manufacturing line set-ups, routine, and preventative maintenance on production equipment.
- Identify and implement improvements to manufacturing processes, tools, jigs, and methods that enhance product quality, efficiency, and manufacturability.
- Maintain accurate and complete batch records, logs, check sheets, and maintenance records in compliance with GMP and quality system requirements.
- Collaborate with cross-functional teams during line validations, engineering builds, or product transfers.
What Skills You Need for Manufacturing Technician:
- Third level qualification in a relevant technical field is advantageous.
- Industry Experience: 2-5 years of hands-on experience in the medical device or pharma industry, operating and maintaining production equipment, and supporting process improvements.
- Working knowledge of QMS and regulatory requirements in the medical device industry, including ISO 13485, MDR, and FDA requirements.
- Excellent communication and organizational skills, ability to work effectively in a team environment, good documentation practices, and strong working knowledge of Microsoft Word, Excel, PowerPoint, etc.
- Knowledge of cleanroom manufacturing processes and methodologies, ability to read technical drawings, process diagrams, and equipment manuals.