Job Description

The Cleanroom Production Technician is responsible for manufacturing, inspecting, testing, and packaging medical devices in a controlled cleanroom environment. This role requires meticulous attention to detail, adherence to strict procedures, and the ability to maintain accurate records throughout the manufacturing process.

The technician will ensure product quality during all stages of production, report any non-conforming events, and support cleanroom operations to maintain compliance with quality and safety standards.

Principal Duties and Responsibilities:

• Manufacture, inspect, test, and package medical devices according to established specifications and procedures.
• Follow and understand company procedures and work instructions with precision and accuracy.
• Accurately document manufacturing activities, ensuring neat and legible records for device history files (DHRs).
• Inspect and test products using various automated and manual equipment, ensuring adherence to quality standards.
• Verify product quality at all stages of the manufacturing process and report any product defects, process deviations, or non-conforming events to cleanroom management.
• Perform daily organization and cleanup of the work area to maintain cleanroom standards.
• Participate in weekly clean-down activities to ensure the cleanroom environment meets regulatory and operational requirements.
• Support other business areas as needed and as trained, ensuring cross-functional collaboration.

Qualifications and Skills:

• Previous experience in a cleanroom environment is advantageous but not required.
• Prior experience in a production or manufacturing environment is beneficial.
• Ability to follow detailed build instructions, procedures, and work instructions with precision.
• Familiarity with using production equipment and tooling as part of the manufacturing process.
• Strong attention to detail and the ability to identify quality issues during production.
• Effective communication skills for reporting defects and collaborating with cleanroom management.
• Self-motivated with the ability to work independently or as part of a team.

Physical Requirements:

• Regularly required to stand, walk, and use hands to handle or feel objects, tools, or controls.
• Frequently required to talk and hear.
• Occasionally required to stoop, kneel, or crouch.
• Must be able to work in a cleanroom environment, adhering to strict hygiene and gowning protocols.
• Ability to lift and/or move up to 25 pounds occasionally.

Zavation Medical Products

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