Job Description

Job Description

Job Description

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.
  1. Tumbling
  2. Blasting
  3. Heat Treat
  4. Laser Welding
  5. Laser Marking
  6. Passivation
  7. Anodize
• 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.
• Other duties and responsibilities are assigned.

QUALIFICATIONS:

Education

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

Experience

• Minimum of 0-2 years’ experience in a regulated manufacturing environment.

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 verbal and written English language communication skills.
• Strong background concerning the usage and care of mechanical metal finishing equipment and processes.
• Must have good organizational skills.

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.)
• Class I, II and/or III Medical Device manufacturing experience

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 50 pounds while moving components or fixtures/racking. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

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