Quality Systems Specialist

Reposted 18 Days Ago
Be an Early Applicant
Indianapolis, IN
In-Office
Mid level
Appliances • Industrial
The Role
The Quality Systems Specialist improves the QMS, ensures compliance, drives CAPA processes, conducts audits, and resolves customer issues.
Summary Generated by Built In
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 [email protected]. 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 works collaboratively to help ensure effective execution of key quality system processes including records management, change control, quality training, design control, and quality data analytics and metrics reporting. The position may also provide cross-functional support for internal and external audits, supplier quality, engineering changes (ECO), document control, and eQMS administration.

Basic Background Requirements:

  • Bachelor’s Degree  or equivalent experience.
  • Minimum 3 years of experience working within a QMS ideally in a regulated industry (medical device manufacturing).
  • Demonstrated knowledge of quality system disciplines including change control, internal audits, quality training, supplier quality management, and document control is highly desirable.
  • Strong analytical ability along with working knowledge of data analysis and quality performance metrics. Experience with Power BI beneficial.
  • Mastery of Microsoft products and working with a QMS system daily.
  • 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).

Top Skills

Microsoft Products
Qms System
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The Company
HQ: Jasper, Indiana
2,481 Employees
Year Founded: 1961

What We Do

Who We Are -
Kimball Electronics is a leading contract manufacturer of durable goods electronics serving a variety of industries on a global scale. Kimball Electronics continues to make the customer the focus of everything we do. Our touch is felt throughout daily life via the markets we serve: Automotive, Industrial, and Medical. Recognized with a reputation for excellence, Kimball Electronics is committed to a high-performance culture that values personal and organizational commitment to quality, reliability, value, speed, and ethical behavior. Our employees know they are part of a corporate culture that builds success for customers while enabling employees to share in the Company’s success through personal, professional, and financial growth.

What We Do -
Kimball Electronics is a preeminent Electronics Manufacturing Services (EMS) provider serving customers around the world. Our contract electronics manufacturing services teams provide manufacturing, engineering and supply chain services, design and testing services, as well as regulatory support processes which utilize common production and support capabilities for a variety of industries globally.

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