Cleanroom Operative

Job Summary:

We are seeking a highly detail-oriented and process-driven Medical Device Production Specialist with direct experience in cleanroom environments (ISO Class 7 or higher). The ideal candidate will be responsible for supporting the manufacturing and assembly of Class I, II, or III medical devices in compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations.

Key Responsibilities:

• Operate within a controlled cleanroom environment, adhering strictly to gowning, hygiene, and contamination control procedures.

• Assemble, inspect, and package medical devices using precision tools and microscopes as needed.

• Maintain compliance with Good Manufacturing Practices (GMP) and ISO 13485 quality standards.

• Follow standard operating procedures (SOPs), batch records, and work instructions for medical device assembly and inspection.

• Perform in-process and final inspections to ensure devices meet all specifications and quality criteria.

• Monitor and maintain cleanroom cleanliness and participate in routine environmental monitoring.

• Document production activities accurately and in real-time using DHRs (Device History Records) and logbooks.

• Support validation activities including IQ/OQ/PQ and new product introductions (NPIs).

• Identify and report any deviations, non-conformities, or quality issues to the production supervisor or quality team.

• Collaborate with engineers, quality assurance, and other cross-functional teams to ensure continuous improvement.

Required Qualifications:

• 1-3 years of experience in medical device manufacturing, preferably in a cleanroom setting.

• Familiarity with FDA regulations, ISO 13485, and GMP requirements.

• Comfortable working in ISO Class 7 or ISO Class 8 cleanroom environments for extended periods.

• Strong attention to detail and manual dexterity for precision assembly.

• Ability to read and interpret technical documents, SOPs, and blueprints.

• Basic computer proficiency (e.g., MES systems, Microsoft Excel).

Preferred Qualifications:

• Experience with assembly of catheters, surgical instruments, or implantable devices.

• Prior exposure to electromechanical assembly, laser welding, or ultrasonic bonding processes.

• Certification or training in Cleanroom Protocols, Lean Manufacturing, or Six Sigma (a plus).