Quality System Auditor

Kimball Electronics • Indianapolis, IN

10d

About The Position

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!
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.

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.

Nice To Haves

• Completion of certified Internal Auditor or Lead Auditor training course can be beneficial.
• Certifications such as Certified Quality Auditor (CQA) can be beneficial.

Responsibilities

• Identifying compliance risks within our processes by scheduling, preparing and executing internal audits by coordinating with cross-functional teams.
• Communicate findings and make improvement recommendations within the organization and ensure they are properly implemented.
• Champion continuous improvement initiatives for our QMS and can influence others with crucial training sessions.
• Lead audits and document appropriately to identify and address areas of improvement
• Educate other departments on regulatory requirements and share best practices

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees