Manufacturing Tech I (1st Shfit)

Fresenius Kabi USA

Warrendale, PA0–2 yrs48m agovia LinkedIn

About the Role

The Manufacturing Technician I for the LVP Service Depot area assists in the diagnosis and repair of medical devices in a cGMP environment. This role requires a high level of attention to detail and the ability to multitask. Under direct supervision, the technician follows departmental SOPs and accurately completes DHRs for each device.

Key Responsibilities

  • Execution of routine service depot operations
  • Inspecting and repairing finished medical devices and pre-production materials
  • Inventory management
  • Continuous Improvement
  • Maintenance of equipment in working area
  • Carry out work in a safe manner, notifying management of safety issues and risks
  • Assumes other duties and responsibilities as directed by supervision
  • Participates in any and all reasonable work activities as assigned by management
  • Assists in the set-up of daily activities ranging from staging service devices for decontamination, provisioning, and service repair per Standard Operating Procedures, Inspecting, Packaging and Labeling of finished products.
  • Maintains equipment and operates production equipment.
  • Handles parts and supply inventory per Standard Operating Procedures.
  • Perform scheduled basic maintenance of equipment, as required.
  • Assist in the assembly and disassembly of process equipment.
  • Cleaning and disinfection of equipment per SOPs and cGMPs.
  • Complete documentation clearly and concisely.
  • Review and Completion of all required documentation per order.

Continuous Improvement

  • Participates in continuous quality improvement.
  • Contribute improvement ideas and suggestions.
  • Attend workshops as required; open to cross training and becoming multi-skilled.

Administration

  • Participate in meetings as needed.

Knowledge and Compliance

  • Maintain a current and comprehensive knowledge of relevant procedures and policies.
  • Compliance with relevant Acts, legal demands, code of conduct and ethical standards.
  • Responsible for ensuring compliance to company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Requirements & Tech Stack

  • GED/High School diploma required.
  • 0 to 2 years’ work experience; experience in a regulated industry is preferred.
  • Internal applicants: 1 year of electro-mechanical assembler experience preferred.
  • Ability to frequently lift/move materials and objects (up to 40 lbs).
  • Ability to complete periods of standing or twist and lift activities during job shift.
  • Ability to distinguish and identify colors.
  • Three-dimensional vision. Ability to judge distance and space relationships.
  • Quality minded and excellent attention to detail.
  • Willing to work as a team player.
  • Excellent attendance and punctuality.
  • Be able to learn and be competent in other core skills related to department.
  • Meet and maintain training requirements.
  • Provide annual performance self-assessment on development plan.
  • Works in time efficient manner while maintaining adherence to all applicable SOPs.

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