New Product Senior Quality Assurance Engineer

 The New Product Senior Quality Assurance Engineer contributes to and leads all aspects of quality related to development and introduction of new products/processes responsible for medical device safety risk management, quality planning in new product development, product/process reliability program management, supplier product/process introduction or improvement, production trouble shooting, or individual measurement and analysis projects.  performing measurements, creating engineering designs, developing plans and keeping design files on all projects; Functioning as a member of cross functional teams by providing technical expertise for projects or subprojects.  
•Knowledge of Design Control Systems and ability to apply project management techniques
•Proficient with utilization of quality tools (FMEA, Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, , FTA, DOE, etc.)
•Administers the safety risk management process for new product development.  
•Administers the quality plan and reliability program on new product development teams
•Provides leadership, consulting and troubleshooting on quality issues or technical problems that arise in product and process development  
•Instructs engineers and technical support staff on quality system requirements  
•Provides written reports, protocols, and personnel assessments as necessary  
•Assures compliance with company Standard Operating Procedures and policies  
•Prepares progress reports & presentations on projects as required.  
EXPERIENCE:
•Five (5) years of experience in engineering practice, quality systems, or supplier management
•Two (2) years of experience participation on a new product development team
•One year of experience in project or program management preferred
•Two (2) years of experience in quality/reliability engineering practice in a medical regulated environment (FDA 21 CFR, ISO 13485, Ability to manage multiple initiatives simultaneously
•Knowledge of Standards Applicable to Medical Device Safety Risk Management (ISO 14971, IEC 60601-1, etc.)  
•Knowledge of Reliability Engineering Principles  
•Knowledge of Change Order System.  
•Ability to perform component engineering design and changes.  
•Strong leadership skills with the ability to influence without direct authority.  
EDUCATION:
•Education Required: Bachelor’s degree in Mechanical or Electrical Engineering, or related field. Quality Certification CRE / CQE
•Education Preferred: Master’s degree or Ph.D. in Mechanical or Electrical Engineering, or related field.  Green or Black belt Six Sigma Certification (DFSS/ DRM or DMAIC)