Production Specialist
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*Note: There is no Visa sponsorship being offered for this position.
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Kimball Medical Solutions provides 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. We offer a 50% match on your first 6% of 401k contribution with opportunity for an employer contribution annually.
2nd Shift: 3p-11p, Monday-Thursday. Shift Premium $1.75
OR
3rd Shift: 11p-7a, Sunday-Thursday. Shift Premium $1.75
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)
