Quality System Team Lead

Position Overview

We are seeking an enthusiastic Quality System Team Lead who is passionate about leadership, regulatory compliance, and continual improvement with a “can do” attitude. This position offers an excellent opportunity lead a team within the Quality department of our quickly growing medical device manufacturing plant. The mission of the Quality System Team Lead is to provide support to all functions within the organization while continuously seeking quantifiable improvements to our Quality Management System and applicable regulations. Join us to lead a dynamic team and make a significant impact on quality and compliance!

Position Summary

The Quality System Team Lead is responsible for supporting the development, implementation, and effectiveness of the Quality Management System (QMS) initiatives and processes at KE Indianapolis. You'll be at the forefront of ensuring compliance in our QMS. You'll manage project assignments to drive successful outcomes, stay updated on the latest QMS standards and regulatory requirements, and guide your team through new and revised standards like ISO 13485 and FDA regulations. You’ll elevate training competencies and assist in management reviews and audits while continually improving our processes. This role reports to the Quality & Regulatory Affairs Manager.

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 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.
• 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):

• Provide coaching, mentorship, and leadership
• Ensure KEIND processes comply with regulatory standards
• Support internal audits to identify and address areas of improvement

Longer Term: (6 to 12 months):

• Solid understanding of KEIND Quality System.
• Identify and lead continuous improvement opportunities
• Act as a liaison with other departments providing cross functional help for all things quality.
• Responsible for Quality System Management
• Educate other departments on regulatory requirements and share best practices