Production Floor Lead, 2nd Shift

Kimball Electronics • Indianapolis, IN

2d • Onsite

About The Position

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.

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.

Requirements

• 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.
• 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 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.
• Maintain regular attendance according to the company’s attendance guidelines.
• Complete Yellow Belt Training (Green Belt Preferred).

Nice To Haves

• Medical manufacturing experience is preferred.
• Complete Yellow Belt Training (Green Belt Preferred).

Responsibilities

• Train, direct and oversee the work of production associates for Medical Device manufacturing processes.
• Assist supervisor in the oversight of work area staff to ensure quality products are manufactured efficiently and effectively in compliance with released documentation and company policy.
• Verify proper batch record documentation according to Product Related Procedures, Quality System Procedures, and Good Documentation Practices.
• Be accountable for a team of associates and their results.
• Identify continuous improvement opportunities, present root cause analysis (including data to support your analysis), and a plan to implement.
• Review and understand procedures and interpret assembly drawings effectively.
• Work on your feet at the actual location of production.
• Reach, bend and lift as required by production requirements.
• Understand business, legal and regulatory requirements.
• Work 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.
• Contribute to 6S & Continuous Improvement (CI) for your area.
• Report production in the ERP system and on Work Order documentation.
• Improve procedures and Processes for production efficiency.
• Provide training for other production specialists.
• Initiate and complete Engineer Change Orders.

Benefits

• 3 weeks of PTO starting your 1st year
• 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

What This Job Offers

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