Production Operator, 1st Shift

Kimball Electronics•Indianapolis, IN

17h•Onsite

About The Position

The mission of the Production Operator is to assemble and pack parts per production procedures, and document production processes while meeting goals of quality, cost and delivery for our customers. This position reports to a Production Supervisor within the Operations department of a growing Medical Device contract manufacturer focused on capital equipment, drug delivery devices and disposables. This position is responsible for assembly, testing, and packaging of finished products per production and quality system procedures using manufacturing machines and equipment, hand tools, custom fixtures, sub-assemblies, parts and fasteners. This includes the proper documentation of manufacturing activities according to production procedures and good manufacturing practices.

Requirements

Attention to detail and good documentation skills
Ability to work on pharmaceutical products with the end patient in mind
Ability to read procedures and interpret assembly drawings
Ability to stand, stoop, bend, reach and lift as required
Ability to analyze situations accurately and follow the applicable procedures
Able to work independently and as a member of a team
The ability to work with all levels of the organization
Ability to understand business, legal and regulatory requirements

Nice To Haves

Medical manufacturing experience is preferred

Responsibilities

Assemble and pack parts per production procedures
Document production processes
Meet goals of quality, cost and delivery for our customers
Assemble, test, and package finished products per production and quality system procedures
Use manufacturing machines and equipment, hand tools, custom fixtures, sub-assemblies, parts and fasteners
Properly document manufacturing activities according to production procedures and good manufacturing practices
Assemble simple devices with short cycle times and high daily volumes
Assemble complex devices with long cycle times and low daily volumes
Operate automated assembly equipment
Operate equipment, fixtures and test stations per procedures and training
Record results as defined by documentation
Verify work in accordance with checklists
Package and label finished product into designated cartons per BOM
React to change productively and handle other tasks that may be assigned
Work overtime as required to provide excellent customer satisfaction
Maintain clean and safe working environment in accordance with company policies
Maintain regular attendance according to the company’s attendance guidelines
Maintain general knowledge of the certification and regulatory requirements contained in ISO-13485, and FDA CFR/GMP Medical Device Regulation
Learn KEIND Quality system requirements
Learn Good Documentation Practices
Build relationships with Operations, Quality and Material Handling team members
Be self-sufficient in several assembly and packaging jobs
Complete Work Orders per the assigned cycle times and schedule
Record complete and accurate information for Device History Records per Good Manufacturing Practices
Learn and adopt Kimball Electronics philosophies and culture
Always work within Procedures
Report production in the ERP system and on Work Order paperwork
Inspect work of previous operator when on a production line
Follow the 5S process for your area
Complete inventory forms as required
Assist in work order setup
Provide training for other production associates on jobs which proficiency has been achieved
Provide improvement ideas for review
Complete Yellow Belt Training