Cleanroom Manufacturing Operator

CQ Medical•New Garden Township, PA

6h•Onsite

About The Position

The Cleanroom Manufacturing Operator is responsible for the precise manufacturing, inspection, and packaging of fiducial markers in a regulated cleanroom environment. The role requires attention to detail, adherence to quality and regulatory standards, and the ability to follow documented procedures to ensure product safety, consistency, and compliance. The operator contributes to a culture of quality and continuous improvement.

Requirements

High school diploma or GED.
Ability to perform repetitive, detail-oriented tasks consistently and accurately.
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.

Nice To Haves

Experience working in a cleanroom, medical device, pharmaceutical, or regulated manufacturing environment.
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.

Responsibilities

Manufacture products according to approved work instructions, SOPs, and batch records.
Perform detailed assembly, handling, and inspection of small, delicate medical device components.
Work in a cleanroom while following gowning, hygiene, and contamination-control protocols.
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 escalate 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.