Production Operator, 3rd Shift

Kimball Electronics•Indianapolis, IN

About The Position

The Production Associate assembles and packs parts according to production procedures and documents manufacturing activities while meeting customer quality, cost, and delivery goals. This role is within the Operations department of a medical-device contract manufacturer focused on capital equipment, drug delivery devices, and disposables, and reports to a Production Specialist. The position involves assembling, testing, and packaging finished products according to production and quality-system procedures. Work uses manufacturing machines and equipment, hand tools, custom fixtures, subassemblies, parts, and fasteners. The associate documents manufacturing activities in accordance with procedures and good manufacturing practices. The schedule is Sunday through Thursday, 11 p.m. to 7 a.m., with a $1.75-per-hour third-shift differential. Overtime may be required.

Requirements

  • Ability to work on pharmaceutical products while meeting high quality standards and maintaining good documentation.
  • Ability to assemble simple and complex devices at short cycle times and high daily volumes.
  • Ability to operate automated assembly equipment and equipment, fixtures, and test stations according to procedures and training.
  • Ability to verify work against checklists and record results.
  • Ability to read procedures and interpret assembly drawings.
  • Ability to work on one’s feet and reach, bend, and lift as required by the job.
  • Ability to analyze situations accurately and follow applicable procedures, working independently and as part of a team.
  • Ability to work with all levels of the organization and adapt productively to changes in work or volume.
  • Ability to perform other assigned tasks and work overtime as required.
  • Ability to maintain regular attendance according to company guidelines.
  • General knowledge of ISO 13485 and FDA CFR/GMP medical-device regulatory requirements.

Responsibilities

  • Assemble simple and complex devices and pack parts according to production procedures.
  • Test and package finished products using manufacturing machines, equipment, hand tools, fixtures, subassemblies, parts, and fasteners.
  • Operate automated assembly equipment, fixtures, and test stations according to procedures and training.
  • Verify work using checklists and record results accurately.
  • Package and label finished products in designated cartons according to the bill of materials.
  • Complete work orders within assigned cycle times and schedules.
  • Maintain complete and accurate Device History Records and report production in the ERP system and on work-order paperwork.
  • Inspect the work of the previous operator when working on a production line.
  • Complete inventory forms and assist with work-order setup as required.
  • Train other production associates on jobs where proficiency has been achieved.
  • Provide improvement ideas and complete Yellow Belt Training.
  • Maintain a clean and safe work environment and follow the 5S process.
  • Maintain regular attendance, follow procedures, and work overtime as required.
  • Build relationships with Operations, Quality, and Material Handling team members.
  • Learn and follow the company’s quality system and good documentation practices.

Benefits

  • Three weeks of PTO starting the first year, in addition to 10 paid holidays.
  • Potential monthly incentive bonus based on company performance.
  • Major health, dental, vision, and complementary insurance coverage starting on day one.
  • Generous 401(k) match and opportunity for an annual employer contribution.
  • $1.75-per-hour third-shift differential.
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