2nd Shift: 3p-11p Monday-Friday

Position Overview

The mission of the Production Specialist is to provide the operations department with essential support to train, direct and oversee the work of production associates for Medical Device manufacturing processes. The production specialist is meticulous, possesses a greater level of knowledge, skills, abilities and continuously strives to improve. 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.

Quick Summary

The Production Specialist is responsible for assisting their supervisor in the oversight of work area staff, to ensure that quality products are manufactured efficiently and effectively in compliance with released documentation and company policy. This includes the verification of proper batch record documentation according to Product Related Procedures, Quality System Procedures, and Good Documentation Practices. In addition, the Production Specialist will be accountable for a team of associates and their results.

Basic Background Requirements

This position will require:

• Medical manufacturing experience is preferred
• Ability to work on pharmaceutical products with the end patient in mind
• Ability to Communicate effectively (verbal, written, documentation)
• Experience with MS Office and comfortable working with different computer programs
• Must be self-motivated, organized, exhibit willingness to change under pressure.
• Must be able to identify continuous improvement opportunities, present root cause analysis (including data to support your analysis), and a plan to implement.
• Able to work independently and as a member of a team
• The ability to work with all levels of the organization
• React to change productively and handle other tasks that may be assigned.
• Ability to review and understand procedures and interpret assembly drawings effectively.
• Ability to work on your feet at the actual location of production.
• Ability to reach, bend and lift as required by production requirements.
• Ability to understand business, legal and regulatory requirements
• Works overtime as required to provide excellent customer satisfaction
• Operate equipment, fixtures and test stations per procedures and training as needed.
• 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

Key Performance Objectives

Short Term: (0 to 3 months)

• Learn and adopt Kimball Electronics philosophies and culture
• Learn KEIND Quality system requirements
• Learn Good Documentation Practices
• Complete inventory forms as required
• Build relationships with Operations, Quality and Material Handling team members
• Maintain clean and safe working environment in accordance with company policies.
• Maintain regular attendance according to the company's attendance guidelines.
• Contribute to 6S & Continuous Improvement (CI) for your area

Midterm: (3 to 6 month)

• Ability to review procedures for accuracy.
• Provide improvement ideas for review & drive implementation
• Report production in the ERP system and on Work Order documentation
• Lead and be accountable for team and their results

Long term: (6 to 12 months)

• Improve procedures and Processes for production efficiency.
• Provide training for other production specialists
• Initiate and complete Engineer Change Orders
• Complete Yellow Belt Training (Green Belt Preferred)