US-: Senior Quality Engineer
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please visit http://sqa.fyicenter.com
Senior Quality Engineer
* Maintain component failure verification and analysis capability. Support component qualifications, manufacturing verifications/validations of products and processes.
* Lead investigation efforts and accurately document investigation plans, supporting data, and conclusions. Lead corrective and preventive action projects.
* Participate on extended core teams as a QA representative. Implement changes from project teams (e.g. design or component changes) into the production stream using change control process. Train other QA associates on changes to production documentation, methods, equipment, specifications, etc.
* Complete additional responsibilities as assigned by QA management.
* Bachelor's Degree in a related field (such as Biological Sciences, Chemistry, Engineering, Computer Science and/or Regulatory Affairs)
* 5 years experience in a regulated environment
* Experience working as a Quality Engineer for instrument based manufacturing product lines
* Experience with design change in a regulated environment such as compliance to 21CFR820, ISO 9001, ISO 13485, ISO 14971, ISO 10993 and/or applicable regulations
* Demonstrated experience supporting R&D in Medical Device or related field
* Knowledge of design controls or previous Quality Assurance experience in an ISO, TS 16949, or Regulatory environment
* Knowledge of validation, equipment calibration, and change control requirements
* Prior experience effectively managing multiple tasks and driving execution of change management plans
* Prior experience leading or managing process control, supplier quality and continuous improvement projects using statistical techniques/tools such as statistical sampling, SPC Six Sigma
* Prior experience in root cause analysis and project management techniques
* Prior experience writing communications that ensure clarity, accuracy and consideration of the audience
* Strong communication skills both written and oral
* Prior experience analyzing data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity
* Experience with Microsoft Office
* Basic skills with Minitab and/or related analytical software programs
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI