Job Description
Key Responsibilities
Set up and operate extrusion equipment according to validated process parameters.
Perform sizing, startup, shutdown, and changeover activities.
Monitor process stability and make realtime adjustments to maintain product quality.
Troubleshoot extrusion, tooling, and downstream equipment issues.
Perform inprocess inspections and dimensional measurements using calipers, micrometers, and vision systems.
Accurately document process data, deviations, and adjustments per GMP requirements.
Support IQ/OQ/PQ activities and validated operating windows.
Perform basic preventive maintenance and cleaning of screws, barrels, dies, and molds.
Follow all safety, quality, and cleanroom procedures.
Required Qualifications
Technical degree or certification in plastics processing, extrusion, or related field preferred.
Handson experience running extrusion machinery (medical industry preferred).
Knowledge of polymer materials such as PVC, TPU, TPE, FEP, or similar.
Experience with GMP, quality systems, and process documentation.
Familiarity with process validation concepts (IQ, OQ, PQ).
Skills and Competencies
Strong mechanical and process troubleshooting skills.
Ability to work independently during setup and sizing phases.
Attention to detail and commitment to product quality.
Ability to support shift coverage and production priorities.
Effective communication and teamwork skills.
Regulatory Compliance:
Stay current with FDA, EU MDR, and other relevant medical device regulations.
Ensure compliance with Good Manufacturing Practices (GMP).
Participate in regulatory audits and inspections.
Maintain required documentation for regulatory submissions.
Medical Material Management:
Manage medical-grade polymer inventory and handling procedures.
Ensure proper documentation and traceability of raw materials.
Oversee the maintenance of material certifications and lot control documentation.
Oversee proper storage conditions for temperature and moisture-sensitive materials.