Precision Cleanroom Operator – Medical Device Assembly

CQ Medical; Toughkenamon (Chester County); On-site; USD 25,000 - 33,000; Full time

Job summary

CQ Medical is seeking a detail-oriented Cleanroom Manufacturing Operator to manufacture, inspect, and package fiducial markers in a regulated environment.

You will follow SOPs, batch records, and FDA/ISO requirements, perform inspections, maintain documentation, and collaborate with Quality, Engineering, and Manufacturing teams to ensure product quality and continuous improvement. This role requires precision and teamwork.

Qualifications

• High school diploma or GED required.
• Experience in clean room, medical device, pharmaceutical, or regulated manufacturing environment preferred.
• Ability to perform repetitive, detail-oriented tasks with consistency and accuracy.
• Strong manual dexterity and comfort working with small components.
• Ability to follow written instructions and procedures precisely.
• Basic computer skills for documentation and recordkeeping.
• Ability to work independently and as part of a team.

Responsibilities

• Manufacture according to approved work instructions, SOPs, and batch records.
• Perform detailed assembly, handling, and inspection of small medical device components.
• Work within a clean room environment while following gowning, hygiene, and contamination control protocols.
• Accurately complete manufacturing documentation, logs, and quality records in compliance with FDA and ISO standards.
• Conduct in-process inspections and visual checks to ensure product quality and conformance.
• Package and label products according to specifications and regulatory requirements.
• Identify, document, and elevate nonconformances, deviations, or potential quality issues.
• Maintain a clean, organized, and compliant work area.
• Participate in training, audits, and continuous improvement initiatives.
• Collaborate with Quality, Engineering, and Manufacturing teams to support production goals.

Skills

Detail-oriented

Manual dexterity

Documentation precision

Teamwork

Independent work

Basic computer skills

Education

High school diploma or GED

Tools

Microscopes

Measurement tools

Visual inspection processes

Job description

CQ Medical is seeking a detail-oriented Cleanroom Manufacturing Operator to manufacture, inspect, and package fiducial markers in a regulated environment.

You will follow SOPs, batch records, and FDA/ISO requirements, perform inspections, maintain documentation, and collaborate with Quality, Engineering, and Manufacturing teams to ensure product quality and continuous improvement. This role requires precision and teamwork.