Process Operator I

2 months ago


Berlin, United States Tomz Corporation Full time
Job DescriptionJob Description

Reporting to Department Manager, this position will have direct responsibility for the processing of parts through various automated 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 inspections on completed components.

ESSENTIAL FUNCTIONS:

  • Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
  • Prepare components to be processed through various automated metal finishing operations. Ex. include loading and un-loading of automated sand blasting or tumbling equipment, racking and un-racking components to support the anodize and passivation line.
  • Perform visual inspections on completed components, as required.
  • 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.

Preferred Skills/Qualifications

  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge of and experience with GMP/ISO standards.
  • Strong background concerning the usage and care of mechanical metal finishing equipment and processes.
  • Ability to use basic hand-held tools to support preventive maintenance activities.
  • Ability to effectively read and understand blueprints, specifications and procedures.
  • Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
  • Strong verbal and written English language communication skills.

5:30pm-4 am - 15% differential
50 hours

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