Process Operator I

TOMZ Corporation; Berlin (CT); On-site; USD 42,000 - 52,000; Full time

Job summary

TOMZ Corporation in Berlin, CT is seeking a Process Operator 1 to support the manufacturing of medical device components. You will oversee processing of parts through metal finishing, inspection, and assembly, while ensuring accurate documentation and adherence to ISO 13485 standards.

The role requires basic hand-tools use, strong attention to detail, and good organizational skills. Familiarity with GMP/ISO requirements is preferred; training and growth opportunities are provided in a regulated,

Qualifications

• High school diploma or equivalent required or transferable manufacturing experience.
• Experience in a regulated manufacturing environment (6 months–2 years) preferred.
• Familiarity with GMP/ISO standards is a plus.

Responsibilities

• Perform visual and basic dimensional inspections on components using micrometers, calipers, microscope, etc.
• Complete and compile documentation related to Quality Inspection standards.
• Ensure material control, identification and traceability for conforming and nonconforming material through manufacturing processes.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize ERP and QMS systems to document inspection activities and controls.
• Follow PPE guidance and safety requirements and TOMZ Quality Management System.

Skills

Hand tools

Attention to detail

Organizational skills

Finishing equipment care

Education

High school diploma or GED

Tools

ERP systems

QMS software

Micrometers

Calipers

Job description

We are hiring a Process Operator 1! Join our team in Berlin, CT!

Summary Of Position

Reporting to the Department Manager, this position will have direct responsibility for the processing of parts through various functions within the Department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, prepare materials to be processed through various operations, and perform basic visual and dimensional inspections on completed components.

Essential Functions

• Prepare and process components through various metal finishing operations.
• Tumbling
• Blasting
• Heat Treat
• Laser Welding
• Laser Marking
• Passivation
• Anodize

Responsibilities

• Perform visual and basic dimensional inspections on completed components, as required using micrometers, calipers, microscope, etc.
• Completes and compiles necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications

• Ability to use basic hand-held tools to support preventive maintenance activities.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Strong background concerning the usage and care of mechanical metal finishing equipment and processes.
• Must have good organizational skills.

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience

• Minimum of 6 months-2 years’ experience in a regulated manufacturing environment.

Preferred Skills

• Ability to effectively read and understand blueprints, specifications, and procedures.
• Knowledge of and experience with GMP/ISO standards.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Strong verbal and written English language communication skills.
• Class I, II and/or III Medical Device manufacturing experience

Physical Requirements

• Ability to bend, stoop, squat, kneel, and lift up to 25 pounds. Team lift or mechanical assistance required for objects over 25 pounds.
• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
• Ability to sit or stand for prolonged periods.