Jeron Electronic Systems, Inc. currently has an opportunity available for a Quality Specialist in Niles, IL.
In this position, you will take ownership of, organize and direct all aspects of our Quality Assurance Program. Serve as the primary point of contact for all QSR regulatory concerns, non-conformance issues, and documentation requests related to QSR compliance.
The ideal candidate will have a thorough understanding of the FDA QSR (21 CFR 820), along with the ability to effectively apply and teach quality principals in a manufacturing environment.
The Quality Specialist will assume responsibility for all QMS related activities, including the following:
Collect, trend and analyze internal performance metrics
Assist leadership and team members with operational data measurement, analysis, and actions
Train staff in QMS, applicable QS requirements, quality concepts, tools, and processes
Assist in the development of procedures, work instructions and other documents
Initiate and facilitate CAPA meetings (corrective / preventive actions) to drive root cause and permanent corrective actions
Assist with internal and external audits
Work with engineering to implement, support, and maintain the DHF and design change procedures
Implement, support, and maintain the DMR and DHR
Knowledge in Quality Management Systems (QMS) applicable to Medical Device manufacturing
Ability to identify problems and initiate corrective and preventive actions
Ability to solve practical and abstract problems and deal with a variety of variables in situations where only limited standardization exists
Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of data with attention to detail and accuracy
Ability to establish priorities and manage time effectively
Possess excellent verbal and written communication skills and can present information effectively
Professional, self-motivated, and focused on continual improvement
Ability to work independently and/or on a team with minimal supervision
Ability to manage multiple tasks simultaneously
Proficient in Microsoft Word, Excel and Power Point
At least 2 years’ experience in a Quality Assurance related role
Medical Device/FDA experience desired
Electronic and mechanical knowledge and skills desired
About Jeron Electronic Systems, Inc.
Jeron Electronic Systems, Inc. is a dynamic organization that sets the standard for excellence with our products. Jeron is a leading manufacturer of communication systems for the healthcare, education, and security markets with an extensive base of distributor partners and installed facilities. Based in the Chicago (Niles, IL) area, Jeron has provided communication solutions since 1965.