Scope:
• This position supports the assembly and production of medical devices in compliance with FDA, GMP, and ISO 13485 standards. The assembler ensures all components are built and documented according to company quality and safety requirements.
Job Summary:
- Basic, repetitive assembly tasks under close supervision.
- Follow the product method sheet to understand the manufacturing process.
- Use hand tools, fixtures, or simple machinery as specified in the method sheet.
- Performs visual inspections for obvious defects.
- Requires minimal technical knowledge.
- Typically, it needs 0–2 years of experience.
Essential Functions & Accountabilities:
- Perform basic assembly operations following approved procedures, drawings, and SOPs.
- Follow GMP, ISO 13485, and cleanroom standards to ensure product safety and compliance.
- Maintain clean, organized, and safe work areas in accordance with company policies.
- Operate hand tools, fixtures, and light equipment as required.
- Communicate effectively with team members and supervisors to meet production goals.
- Participate in training and continuous improvement activities.
- Meets all production requirements and performance standards as defined by area Supervisor
Travel:
- No regular travel required; occasional training travel may occur.
Qualifications
Essential Functions & Accountabilities:
- Perform basic assembly operations following approved procedures, drawings, and SOPs.
- Follow GMP, ISO 13485, and cleanroom standards to ensure product safety and compliance.
- Maintain clean, organized, and safe work areas in accordance with company policies.
- Operate hand tools, fixtures, and light equipment as required.
- Communicate effectively with team members and supervisors to meet production goals.
- Participate in training and continuous improvement activities.
- Meets all production requirements and performance standards as defined by area Supervisor
Travel:
- No regular travel required; occasional training travel may occur.
Qualifications
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