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Quality Systems Specialist

Kimball Electronics
Posted a month ago, valid for 17 days
Location

Indianapolis, IN 46262, US

Salary

$36.46 - $43.75 per hour

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Contract type

Full Time

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Sonic Summary

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  • Kimball Electronics is seeking a Quality Systems Specialist for their Medical Device Contract Manufacturing division in Indianapolis, IN.
  • The position requires a minimum of 3 years of experience working within a Quality Management System (QMS) in a regulated industry, preferably medical device manufacturing.
  • Candidates should possess a Bachelor's Degree or equivalent experience, and familiarity with complaint management, internal audits, and CAPA processes is highly desirable.
  • The role offers competitive benefits starting from the first day, including medical, dental, vision, and a 401K matching program.
  • Note that there is no Visa sponsorship available for this position.

We are committed to providing reasonable accommodations for individuals with disabilities in our job application process. If you need assistance or an accommodation during the application or recruitment process due to a disability, you may contact us at KEIrecruiting@Kimballelectronics.com. We will treat all requests for accommodations discreetly.

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

Kimball Electronics does not accept agency resumes. Please do not forward resumes to any recruiting alias or employee. Kimball Electronics is not responsible for any fees related to unsolicited resumes.

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.

Position Overview

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.

Basic Background Requirements:

Bachelor’s Degree  or equivalent experience.

Minimum 3 years experience working within a QMS ideally in a regulated industry (medical device manufacturing).

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

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.

Key Performance Objectives

Short Term: (0 to 3 months)

  • Learn about Kimball Vision and Guiding Principles.
  • Learn the KEI systems to understand and be able to communicate to all levels of the organization.
  • Develop solid relationships with internal customers and external customers.
  • Learn KEIND Quality System and SOP requirements.

Midterm: (3 to 6 months)

  • Support and coach personnel in CAPA and QMS processes.
  • Participate in audits and help drive root cause investigations.
  • Ensure processes align with regulatory standards.

Long Term: 6-12 months +

  • Demonstrate solid understanding of the site’s QMS.
  • Facilitate QMS improvements, data trending, and reporting to leadership.
  • Serve as a key partner to cross‑functional teams on compliance and quality initiatives.

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Kimball Electronics we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

We’re proud to be an equal opportunity employer and consider qualified applicants without regard to race, color, religion, sex, national origin, ancestry, age, genetic information, sexual orientation, gender identity, marital or family status, veteran status, medical condition or disability or any other characteristic protected by applicable federal, state, or local law.

We will consider for employment qualified candidates with arrest and conviction records, consistent with applicable law (including, for example, the San Francisco Fair Chance Ordinance for roles based in San Francisco).




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