Extrusion Technician

Responsibilities

• This involves but is not limited to:
• Clean down and set up extrusion lines in adherence of line cleaning procedures and process set up in Work Orders and Work Instructions.
• Dry materials, as required, and load to hoppers. Carry out moisture checks as required.
• Size tubing to meet customer and FM COS dimensional, functional and visual specifications
• Ensure First Article inspections are completed.
• Monitor production and adjust extrusion parameters within acceptable ranges to optimise tubing quality ensuring tubing is run as close to nominal as possible unless instructed otherwise.
• Complete documentation or ensure documentation is completed including process parameter monitoring and in process inspection
• Shut down extruders at the completion of run, finalise and sign documentation and ensure tubing is packaged and labelled correctly.
• Maintain excellent housekeeping, GMP and GDP
• Assist the company to achieve the Company goals especially with regard to delivery on time, quality and compliance with Customer and FM COS specifications including packaging, labelling, etc.

Qualifications

• The minimum criteria for the job candidate are specified.
• Required:
• Experience and knowledge of medical device environment including Clean room manufacture, validations, process controls, etc.
• Desirable:
• Ideally Certification in Polymer Science or Mechanical Engineering
• Ideally Experience in extrusion of medical tubing including multi-lumen, co-extrusions, thin wall tubing, tight tolerance tubing, etc.
• Knowledge and understanding of ISO 13485 and FDA 21 CFR Part 820 QMSR requirements an advantage