SQAFYI - Software QA Resource - FYI

US-IN-Indianapolis: Quality Control Analyst

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 05-Apr-2013

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 this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI

US-IN-Indianapolis: Quality Control Analyst