Position Overview
The Cleanroom Preparation Technician is responsible for cleaning, inspecting, and preparing components for the assembly of Pi-Cardia medical devices in a controlled ISO 7 cleanroom environment. The role requires strict adherence to approved work instructions, quality standards, and documentation requirements to ensure compliance with company and regulatory requirements.
Responsibilities
- Work in an ISO 7 cleanroom environment in accordance with cleanroom procedures and gowning requirements.
- Clean, inspect, and prepare components for medical device assembly according to approved work instructions.
- Accurately record activities and maintain documentation within the ERP system.
- Complete production records, preparation documentation, and related forms in compliance with quality system requirements.
- Identify and report quality issues, deviations, or nonconformities to the Production Manager.
- Maintain a clean, organized, and compliant work environment.
- Collaborate effectively with Production, Quality, and Operations teams.
REQUIREMENTS
- Previous experience working in an ISO 7 cleanroom environment, preferably in the medical device industry.
- Excellent fine motor skills and manual dexterity.
- Strong attention to detail, accuracy, and consistency.
- Ability to follow written procedures and maintain accurate documentation.
- Ability to work effectively as part of a team.
- Ability to perform routine production tasks that require prolonged standing and manual handling of components and materials.
