Sr. Quality Engineer to $95k - Biomedical

Job Description:
Immediate need for a Sr. Quality Engineer to sustain and drive new product Quality Engineering activities including verification and validation, design control, test methods and quality systems development and improvement. Responsibilities include - Support product verification and validation for new and existing products - Develop protocols and prepare reports - Develop, implement and administer various quality systems(including database applications for the analysis and reporting of quality system data such as post-market data). - Conduct/coordinate independent testing such as Biocompatibility, EMC testing, Shelf life, Product and Process Validation, Sterilization Validation, Reliability engineering including test plan development and execution. -Support company-wide training. - Investigate sources of quality problems form CAPA and complaints . - summarize, analyze, draw conclusions and make appropriate decisions from test results or other process findings. - Chair Material Review Board (MRB); assure time disposition of non-conforming products. - Interface directly with engineers and outside regulatory agencies (TUV,UL). - Comply with ISO and QSR requirements. This position requires a minimum of an undergraduate degree in a technical field relevant to the biomedical industry, preferably Engineering. - Minimum 5 years in a medical industry. - Specific experience in capital equipment (electromechanical, software controlled) and disposables highly desirable. -Electrical engineering and/or software quality assurance education and/or experience extremely helpful. -Sound knowledge and experience related to medical device design control process. -Use of sound judgment in determining appropriate sample sizes and statistical methods. -Strong interpersonal communication skills; both written and verbal, strong attention to detail. If you match the qualifications, apply today for an opportunity to work with a leading medical device company! You can view all of our jobs online at http://www.act-1.com/?sc=11

Job Experience:
call for details, Access, Excel

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