US-IN-Indianapolis: Quality Control Analyst
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please visit http://sqa.fyicenter.com
Quality Assurance/Quality Control Analyst
* Provide QA oversight for component manufacturing and final assembly activities
* Serves as auditor for review, authorization, disposition of device history records.
* Perform device constituent testing for release of production lots and stability testing.
* Perform document control activities related to the management of Quality System documentation and records.
* Develop/maintain QA/QC procedures.
* Manage electronic records for product building. Utilize sytem and knowledge of pending non-conformance and change control activities to determine if all appropriate corrective and/or preventive actions have been completed prior to release of product.
* Initiate non-conformance reports as required.
* Perform Quality/Product investigations as assigned, including determination of root cause and propose disposition of non-conforming materials. Develop proposals for related corrective and preventive actions.
* Review product, process and engineering change requests, validations and non-standard processes as assigned.
* Perform other related duties and special tasks as directed.
* B. S. Engineering, Chemistry, Medical Technology or other science-related degree, or other bachelor's degree with commensurate work experience.
* 2 - 4 years related experience in regulated medical device manufacturing, pharmaceutical manufacturing or laboratory environment. 1+years of experience may be considered if directly related to combination product medical device manufacturing, medical device molding and/or process validation.
* Prefer individual with one or more ASQ certifications.
* Demonstrated competency in implementation and maintenance of Quality Systems is a plus.
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI