Quality Systems Specialist
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Job Location:
Indianapolis, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 . 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 Systems Specialist who will play a key role in supporting and maintaining a robust Quality Management System (QMS) that meets customer regulatory and internal requirements. This role strengthens organizational compliance drives continual improvement and works collaboratively to help ensure effective execution of key quality system processes including records management change control quality training design control and quality data analytics and metrics reporting. The position may also provide cross-functional support for internal and external audits supplier quality engineering changes (ECO) document control and eQMS administration.
Basic Background Requirements:
- Bachelors Degree or equivalent experience.
- Minimum 3 years of experience working within a QMS ideally in a regulated industry (medical device manufacturing).
- Demonstrated knowledge of quality system disciplines including change control internal audits quality training supplier quality management and document control is highly desirable.
- Strong analytical ability along with working knowledge of data analysis and quality performance metrics. Experience with Power BI beneficial.
- Mastery of Microsoft products and working with a QMS system daily.
- Excels at clear timely communication with internal stakeholders and external customers to support collaboration and results.
- Strive for 100% say do ratio.
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 and SOP requirements.
Midterm: (3 to 6 months)
- Support and coach personnel in CAPA and QMS processes.
- Participate in audits and help drive root cause investigations.
- Ensure processes align with regulatory standards.
Long Term: 6-12 months
- Demonstrate solid understanding of the sites QMS.
- Facilitate QMS improvements data trending and reporting to leadership.
- Serve as a key partner to crossfunctional teams on compliance and quality initiatives.
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).
Required Experience:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
Kimball Electronics offers complete product life cycle support for electronic manufacturing assemblies in the Medical, Industrial, Automotive, and Public Safety market segments. Our electronics design and electronic manufacturing services (EMS) core focus is vital in the creation of d ... View more
