Production Operator, 1st Shift

Position Overview

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.

Responsibilities

• 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
• Proper documentation of manufacturing activities according to production procedures and good manufacturing practices
• Operate equipment, fixtures and test stations per procedures and training; record results as defined by documentation
• Verification of work in accordance with checklists
• Packaging and labeling of finished product into designated cartons per BOM
• Record complete and accurate information for Device History Records per Good Manufacturing Practices
• Report production in the ERP system and on Work Order paperwork
• Inspect work of previous operator when on a production line
• 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
• Maintain clean and safe working environment in accordance with company policies
• Maintain regular attendance according to the company's attendance guidelines
• Work overtime as required to provide excellent customer satisfaction
• Always work within Procedures
• Follow the 5S process for your area

Requirements

• Attention to detail and good documentation skills
• Ability to work on pharmaceutical products with the end patient in mind
• 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
• 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
• Ability to work with all levels of the organization
• React to change productively and handle other tasks that may be assigned
• Ability to understand business, legal and regulatory requirements
• Maintain general knowledge of the certification and regulatory requirements contained in ISO-13485, and FDA CFR/GMP Medical Device Regulation

Qualifications

• Medical manufacturing experience is preferred

Skills

• Complete Yellow Belt Training (within 6-12 months)

Performance Objectives

Short Term (0 to 3 months):

• Learn KEIND Quality system requirements
• Learn Good Documentation Practices
• Build relationships with Operations, Quality and Material Handling team members
• Self-sufficient in several assembly and packaging jobs
• Complete Work Orders per the assigned cycle times and schedule
• Learn and adopt Kimball Electronics philosophies and culture
• Maintain clean and safe working environment in accordance with company policies
• Maintain regular attendance according to the company's attendance guidelines
• Always works within Procedures
• Works overtime as required
• Report production in the ERP system and on Work Order paperwork
• Follow the 5S process for your area

Midterm (3 to 6 months):

• Complete inventory forms as required
• Assist in work order setup

Long Term (6 to 12 months):

• Provide training for other production associates on jobs which proficiency has been achieved
• Provide improvement ideas for review
• Complete Yellow Belt Training

Benefits

• 3 weeks of PTO starting your 1st year in addition to 10 paid holidays
• Potential monthly incentive bonus based on company performance
• Major health, dental, vision, and complementary insurances starting day 1
• 50% match on your first 6% of 401k contribution with opportunity for an employer contribution annually

Schedule

1st Shift, Monday-Friday, 7am-3pm

Pay

Note: There is no Visa sponsorship being offered for this position.