Quality Systems Specialist

Kimball Electronics • Indianapolis, IN

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About The Position

Kimball Medical Solutions is a Medical Device Contract Manufacturer in Indianapolis, IN and we are looking for a Quality Systems Specialist who will play a key role in supporting and maintaining a robust Quality Management System (QMS) that meets customer, regulatory, and internal requirements. This role strengthens organizational compliance, drives continual improvement, and ensures effective execution of corrective and preventive action (CAPA) processes. The position collaborates cross‑functionally and is essential to supporting and conducting audits, documentation control, customer issue resolution, and QMS training initiatives. Assisting with engineering change orders (ECO) and participate in continual improvement initiatives and document process enhancements. Processing product complaints, documentation and investigations to help analyze customer issues and determine root cause and support a solution.

Requirements

• Bachelor’s Degree or equivalent experience.
• Minimum 3 years experience working within a QMS ideally in a regulated industry (medical device manufacturing).
• Mastery of Microsoft products and working with a QMS system daily.
• Demonstrated ability to perform root cause analysis and drive corrective actions to address technical product or process issues and support continuous improvement initiatives.
• Excels at clear, timely communication with internal stakeholders and external customers to support collaboration and results.
• Strive for 100% say do ratio.

Nice To Haves

• Experience with complaint management, internal audits, CAPA processes or document control is highly desirable.

Responsibilities

• Supporting and maintaining a robust Quality Management System (QMS) that meets customer, regulatory, and internal requirements.
• Strengthening organizational compliance
• Driving continual improvement
• Ensuring effective execution of corrective and preventive action (CAPA) processes
• Supporting and conducting audits
• Documentation control
• Customer issue resolution
• QMS training initiatives
• Assisting with engineering change orders (ECO)
• Participating in continual improvement initiatives
• Documenting process enhancements
• Processing product complaints, documentation and investigations to help analyze customer issues and determine root cause and support a solution.

Benefits

• Your benefits start after the first day on the job with various medical, dental, vision and other great benefits for choices as well as the fantastic matching program from our 401K plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level