Quality System Auditor

Location: Indianapolis

Quality System Auditor page is loaded## Quality System Auditor locations:
Kimball Electronics Indianapolis time type:
Full time posted on:
Posted 2 Days Agojob requisition :
R2026134###
* 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
* KEIrecr*. 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.
*** Position Overview
** We are seeking an enthusiastic Quality System Auditor who is passionate about regulatory compliance, accuracy, and continual improvement with a “can do” attitude. This position offers an excellent opportunity to lead internal audits and recommend corrective actions within our quickly growing medical device manufacturing plant. The mission of the Quality System Auditor is to contribute to Kimball Medical Solutions’ success by leading and managing internal audits to ensure the highest standards of quality and regulatory compliance.

Join us to make a significant impact on quality and compliance!
** Position Summary
** The Quality System Auditor is responsible for identifying compliance risks within our processes by scheduling, preparing and executing internal audits by coordinating with cross-functional teams. You will communicate findings and make improvement recommendations within the organization and ensure they are properly implemented. You will champion continuous improvement initiatives for our QMS and can influence others with crucial training sessions. You'll be at the forefront of ensuring compliance in our QMS.

This role reports to the Quality Systems Team Lead.

Basic Background Requirements:
* Bachelor’s degree or equivalent experience.
* Minimum of two years experience in quality management systems, particularly in medical device manufacturing.
* Working knowledge of FDA regulations (21 CFR Part 820) and ISO 13485 standards.
* Experience in conducting internal audits.
* Ability to analyze data and implement corrective actions.
* Strong verbal and written communication skills across all levels of the company
* Effective problem-solving and decision-making abilities.
* High level of accuracy and attention to detail.
* Completion of certified Internal Auditor or Lead Auditor training course can be beneficial.
* Certifications such as Certified Quality Auditor (CQA) can be beneficial.

Key Performance Objectives Short Term: (0 to 3 months):
* Learn about Kimball Vision and Guiding Principles.
* Learn the Kimball systems to understand and be able to communicate to all levels of the organization.
* Develop solid relationships with internal stakeholders
* Learn company Quality System requirements.
* Support ISO 13485 certification, FDA 21 CFR part 820, 4 and 11 other foreign regulatory bodies title 21 as required

Mid Term: (3 to 6 months):
* Ensure company processes comply with regulatory standards
* Lead audits and document appropriately to identify and address areas of improvement

Longer Term: (6 to 12 months):
* Identify and lead continuous improvement opportunities
* Educate other departments on regulatory requirements and share best practices###
* 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)
** We share the organization's vision and goals, and acknowledge that achieving them is only possible with the dedication and skills of our employees.
* We demonstrate confidence in employees' ability to make positive contributions beyond their day-to-day job duties.
* We create very specific opportunities for worker involvement, but also make it clear that input is welcome at any time.
* We provide training to help employees develop, present and carry out their ideas.
* We coach managers to facilitate rather than instruct, and hold them accountable for encouraging and supporting improvement and innovation within their department.
* We empower workers to implement small-scale changes on their own, and keep them apprised of the status of those requiring management approval.
* We recognize employees not only for their achievements, but also their efforts.
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