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Quality Engineer Cambridge United States,  


Posted on : 07 May 2017

Project Description

Tracking Code BC17-R-013 Job Description Bio-Rad Laboratories Digital Biology Center – Cambridge (DBC-C), provides the only fully-integrated DNA sequencing platform designed to meet the work-flow requirements of both research and clinical laboratories; offering both a fully integrated sequencing platform and consumables to power the system.  We are seeking an individual with BS in a related technical field with 0-3 years experience to support DBC-C quality engineering efforts, including quality engineering, production support efforts, validation, and testing. Provide statistical support as needed throughout the plant. Responsibilities: Support Quality Engineering efforts related to process engineering. Support process improvement efforts and quality management system process lean initiatives. Support Risk Management initiatives for post-launch products. Support manufacturing in procedure and process specification development and in performing component qualification, process validations, etc. Support internal audit process as needed. May represent company with suppliers in resolving technical issues. Conduct research, analysis, and investigation or issues as assigned. Required Skills Working knowledge of statistical process control techniques. Basic knowledge of and application of principles and theories of quality engineering. Knowledge of Risk Management using ISO 14971 and risk management tools such as PHA, FTA, and FMEA. Communication, computer, and technical skills. Statistical knowledge (DOE, SPC, hypothesis testing, sample comparison). Computer literate (i.e. data-base development, statistical software and analysis, word processing for report generation, etc.). Problem solving skills. Ability to operate and communicate effectively with multiple teams. Able to understand blue prints, tolerance analysis and related knowledge. Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems and conflicts.   Required Experience 0-3 years experience or equivalent combination of education and experience. Bachelor’s degree or equivalent in a related technical discipline. Basic knowledge of and application of principles and theories of quality engineering. Basic knowledge of design controls and 21 CFR 820, ISO 13485, ISO 14971, and applicable medical device regulations and guidance.   EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age Employer   To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.   Job Location Cambridge, Massachusetts, United States Department DBCC - Quality and Regulatory (10925) Position Type Full-Time/Regular

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Cambridge Massachusetts United States

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