Quality Engineer – $43 / hr
Nemera (via FactoryFix.com)
Buffalo Grove, Illinois
Expiry Date :
Thu, 08 Apr 2021 23:59:59 GMT
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As a result of recent and expected organizational growth as well as the recent COVID-19/Coronavirus pandemic, our client Nemera is looking to expand their team through the addition of_THREE_Quality Engineers for their plant in Buffalo Grove, Illinois.Nemera’s vision is to be the most patient-centric drug delivery device company. As an organization dedicated to putting patients first, they utilize plastic injection molding and high speed automation to manufacture drug delivery devices that truly improve patients lives around the world.THESE ARE DIRECT HIRE OPPORTUNITIESLOCATED IN BUFFALO GROVE, ILLINOIS.
_POSITION #1_: Reporting to the Lead Quality Engineer, the_VALIDATION AND PROJECT SUPPORT QUALITY ENGINEER_will focus on supporting pharmaceutical and biotechnology clients with projects in varying developmental and FDA approval stages, by assisting with documentation and project work. Partnering with Production and our Manufacturing Technology team, the Quality Engineer will coordinate and manage the execution of IQ/OQ/PQ validations, create written protocols, and act as a liaison between Nemera and customers for quality related activities such as creating process control plans, pFMEAs, risk analysis, etc.
_POSITION #2_: Working alongside a Global Project Leader, the_QMS QUALITY ENGINEER_ will act in a Project Manager and Quality Engineer capacity to assist in the selection, implementation, and piloting of a new Quality Management System (QMS) at the Buffalo Grove plant, prior to global implementation. The QE will also manage the implementation of an electronic device history file project at the local level. Post-implementation, the QE will be the subject matter expert for these Quality Systems, acting in an ongoing administrative capacity to monitor and manage the systems.
_POSITION #3_: Reporting to the Plant Quality Manager, the_SUPPLIER QUALITY AND INTERNAL AUDIT MANAGER_ is responsible for managing overall supplier quality by traveling to suppliers for auditing, continuous improvement activities, and overall supplier quality management. The Supplier Quality and Internal Audit Manager will alsomanaging the internal audit processes and activities for the Buffalo Grove plant.
Youll help achieve Nemera’s corporate growth goals by bringing these skills:
* Ability to execute duties in a fast-paced, manufacturing environment, both independently and in conjunction with cross functional and global teams.
* High School Diploma or GED equivalent required. Bachelors degree in Engineering, Science or related field strongly desired.
* 3 or more years of experience in a quality position preferred, with a background focused around medical device manufacturing activities (examples include participating in the IQ/OQ/PQ validation process, customer complaint management,developing and implementing QMS systems, supplier quality management, auditing, etc)
* Excellent customer-facing communication skills with the ability to understand, read, write and speak English required
* Must have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge.
* Six-sigma experience, training or certification preferred
* Intermediate level computer skills, including Microsoft Office, applications required
* SAP and Minitab experience preferred