Hybrid Quality Assurance Team Lead bei Kimball Electronics

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 Assurance Team Leader.  This role will report directly to the Quality & Regulatory Manager and plays an integral part in leading our validation group, metrology, regulatory compliance and helping maintain our quality management system.  Ensuring adherence to ISO 13485 standards with a “can do” attitude ensuring product life cycle compliance, offering expert guidance on regulatory matters and acting as back up to the Quality & Regulatory Manager.  

Success in this position hinges on strong problem-solving abilities, effective communication, precise documentation, and excellent time management. Personal attributes such as openness, patience, and dependability are essential, as is deep technical proficiency in regulatory standards, metrology, supplier quality, auditing, and Lean Six Sigma methodologies. Leadership extends beyond oversight—mentoring, driving positive change, and balancing business priorities are vital components of this dynamic role.

Basic Background Requirements:

• Bachelor’s degree or equivalent experience
• Extensive experience in quality management systems, particularly in medical device manufacturing.
• Familiarity with FDA regulations (21 CFR Part 820) and ISO 13485 standards
• Proven track record of leading teams and managing multiple projects.
• Ability to provide guidance and mentorship to team members to foster their professional growth
• Experience in conducting internal and external 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
• Certifications such as Six Sigma, Certified Quality Engineer (CQE), or 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 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 requirements.

Mid Term: (3 to 6 months):

• Provide coaching, mentorship, and leadership
• Ensure KEIND processes comply with regulatory standards
• Lead root cause analysis investigations and oversee the implementation of robust corrective and preventative actions
• Support internal audits to identify and address areas of improvement

Longer Term: (6 to 12 months):

• Solid understanding of KEIND Quality System.
• Prepare and present regular quality performance reports to senior management, highlighting achievements, trends and areas for improvement
• Act as a liaison with other departments providing cross functional help for all things quality.
• Educate other departments on regulatory requirements and share best practices