Quality System Team Lead
Quality System Team Lead
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1 Vacancy
Job Description
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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. Youll be at the forefront of ensuring compliance in our QMS. Youll 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. Youll 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:
- Bachelors 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
Dont 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 dont necessarily meet every requirement we encourage you to apply. You may be the right candidate for this role or other roles!
Were 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)
Employment Type
Full-Time
