Production Operator, 3rd Shift

Kimball Electronics • Indianapolis, IN

3d

About The Position

The Production Associate assembles, tests, and packages finished products according to production and quality system procedures, meeting customer goals for quality, cost, and delivery. The work uses manufacturing machines and equipment, hand tools, custom fixtures, sub-assemblies, parts, and fasteners, and requires documenting manufacturing activities in accordance with production procedures and good manufacturing practices. The position is in the Operations department of a medical device contract manufacturer producing capital equipment, drug delivery devices, and disposables, and reports to a Production Specialist.

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. The role includes learning the company quality system and good documentation practices, completing work orders, maintaining accurate device history records, reporting production in the ERP system and on work order paperwork, inspecting work from the previous operator, and maintaining a clean and safe work area. Over time, the associate may assist with work order setup and inventory forms, train other associates on tasks they have mastered, contribute improvement ideas, and complete Yellow Belt training.

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.
• Ability to operate equipment, fixtures, and test stations according to procedures and training.
• 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 while working independently and as part of a team.
• Ability to work with all levels of the organization and respond productively to change and volume.
• Ability to maintain regular attendance and work overtime as required.
• General knowledge of certification and regulatory requirements contained in ISO 13485 and FDA CFR/GMP medical device regulations.

Responsibilities

• Assemble simple and complex devices according to production procedures and within required cycle times and production volumes.
• Operate automated assembly equipment, fixtures, and test stations according to procedures and training.
• Test finished products and verify work using checklists, recording results accurately.
• Package and label finished products into designated cartons according to the bill of materials.
• Document manufacturing activities, including complete and accurate Device History Records, in accordance with Good Manufacturing Practices and documentation requirements.
• Complete work orders according to assigned cycle times and schedules, 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.
• Maintain a clean and safe work environment and follow the 5S process for the assigned area.
• Maintain regular attendance in accordance with company guidelines and work within established procedures.
• Complete inventory forms and assist with work order setup as required.
• Train other production associates on jobs for which proficiency has been achieved.
• Provide improvement ideas for review and complete Yellow Belt training.
• Work overtime as required to support customer satisfaction.
• Adapt to changes in work and production volume, handle other assigned tasks, and work independently and as part of a team.

Benefits

• Three weeks of PTO starting in the first year.
• 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) contribution match, with an opportunity for an annual employer contribution.
• $1.75 per hour third-shift differential.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed