Job Summary
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.
Essential Duties & Responsibilities
- 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 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
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
- Attention to detail
- Quality mindset
- Accountability and reliability
- Team collaboration
- Compliance and safety awareness
- Continuous improvement orientation