Cleanroom Manufacturing Operator

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

The Cleanroom Manufacturing Operator is responsible for the precise manufacturing, inspection, and packaging of fiducial markers in a regulated cleanroom environment. This role requires strong attention to detail, adherence to quality and regulatory standards, and the ability to follow documented procedures to ensure product safety, consistency, and compliance. The ideal candidate takes pride in precision work, understands the importance of sterile environments, and contributes to a culture of quality and continuous improvement.

• Manufacture according to approved work instructions, SOPs, and batch records
• Perform detailed assembly, handling, and inspection of small, delicate 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

Required Qualifications

• High school diploma or GED required
• Experience working in a 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

Preferred Qualifications

• Previous experience manufacturing implantable or Class II/III medical devices
• Familiarity with FDA QSR, ISO 13485, or GMP environments
• Experience with microscopes, measurement tools, or visual inspection processes
• Understanding of traceability, batch records, and quality documentation

Physical & Work Environment Requirements

• Ability to sit or stand for extended periods
• Ability to perform fine motor tasks under magnification
• Ability to wear clean room PPE (gowning, gloves, masks) for prolonged periods
• Must be able to lift up to 20 pounds as required
• Work performed primarily in a controlled clean room environment

Core Competencies

• Quality mindset
• Accountability and reliability
• Team collaboration
• Compliance and safety awareness

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.