Position Summary
The Injection Molding Operator is responsible for operating injection molding machines and the product manufactured in a regulated healthcare manufacturing environment.
This role ensures safe, efficient, and compliant production of healthcare components in accordance with ISO 13485 and 21 CFR Part 820 requirements.
Essential Duties and Responsibilities
• Operate injection molding machines and auxiliary equipment per approved work instructions and qualified training.
• Perform machine start-up, normal operation, and shutdown activities, per approved work instructions and qualified training.
• Conduct visual inspections and basic in-process quality checks based upon training and qualification.
• Perform line clearance and material segregation activities during changeovers.
• Accurately complete production and traceability documentation.
• Identify and report non-conforming products and materials.
• Follow GMP, EHS, and cleanroom requirements at all times within the environment.
Required Qualifications
Education: Secondary school education or equivalent.
Experience: Manufacturing experience preferred; injection molding experience advantageous.
Required Skills and Competencies
• Ability to follow detailed work instructions.
• Attention to detail and manual dexterity.
• Basic understanding of quality and safety systems.
• Ability to speak and read English
• Willingness to work shifts.
Training Requirements
• EHS and machine safety training. (Provided)
• Injection molding operator qualification. (Provided)
• Line clearance training. (Provided)
• GMP / Healthcare awareness. (Provided)
Regulatory Alignment
This position supports compliance with ISO 13485 (Medical Devices Quality Management Systems) and 21 CFR Part 820 (FDA Quality System Regulation).
Working Conditions
• Manufacturing environment.
• Standing and manual handling requirements.
• Cleanroom or controlled environment as required.