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.