US-IL-Chicagoland: Senior Quality Assurance Engineer
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please visit http://sqa.fyicenter.com
Senior Quality Assurance Engineer
Participate in the product development process as required to ensure that customer requirements are met.
Perform mechanical product validation testing, develop test methods, protocols, and issue reports as needed.
Support the process and product FMEA, and Risk Management activities.
Lead and facilitate CAPA project teams as required to ensure continuous quality improvement.
Assume the facility customer complaint responsibilities regarding failure analysis, root-cause investigation, and corrective action as required per corporate policy.
Participate in the development, execution, analysis and reporting of first-article qualification and process validations at both SAI and suppliers facilities as required
Perform and document equipment and process Capability Studies.
Conduct analytical testing and root cause analysis for process nonconformance.
Develop and prepare facility quality performance reports, charts, and graphs.
Conduct comparative tests on competitive mechanical products, issue evaluation reports.
Lead six sigma projects and work within cross functional teams
Technical 4-year degree, preferably Bachelor of Science in Engineering, with ASQ certification credentials.
Minimum 3 years Quality Control experience in a medical device manufacturing facility. Familiarity with quality engineering methods.
1 year of supervisory experience is preferred.
Excellent computer skills. Experience with MS Office applications. Knowledge of FDA regulations and ISO 13485 standard.
Must possess excellent written and verbal communication skills to communicate effectively with all levels within the organization.
Demonstrated proficiency in the use of databases, spreadsheets, and statistical software.
Excellent computer skills. Experience with MS Office applications.
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Team SQAFYI - Software QA Resource FYI