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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
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)