Operator II

About the role

Under direct supervision, responsible for processing patient specific medical device products in a controlled environment. Hours: 1st shift 6–2 M–F. Employee must be flexible as this is a time-based process which can create the possibility of split shifts on rare occasions.

Responsibilities

• Perform everyday duties as an operator in a quality-controlled environment.
• Work in an FDA regulated controlled environment (cleanroom) performing tasks such as running a 3D printer, air blast, coating, sterile packaging.
• Use measurement devices, i.e. weight scales, calibration tools.
• Conduct physical inventory in the designated area.
• Maintain 5S order and cleanliness.
• Adhere to all safety rules and use required protective equipment.
• Perform routine equipment set-up, operation, and adjustment.
• Maintain orderly work area, cleaning area and machines as needed.
• Maintain necessary documentation.
• May perform basic quality auditing, testing, and troubleshooting functions.
• Ensure that assigned area is clean and organized.
• Work direction may additionally be communicated verbally through visual aids and set-up sheets.
• Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
• Comply and follow all procedures within the company security policy.

Requirements

• High school diploma or equivalent required; and six months to one-year experience; or equivalent combination of education and experience.
• Must be able to obtain and maintain all required job related certifications.