Quality Engineer II, Design Assurance

Position Summary

As a member of a cross-functional team, the Quality Engineer II, Design Assurance is responsible for identifying and implementing quality improvement measures to ensure state of the art manufacturing of Intra Aortic Balloon Catheters.  Reporting to an experienced engineer, the position identifies and implements production and process control improvements in extrusion, bonding, balloon wrapping, and manual assembly.  As the voice of Quality, the Quality Engineer will champion best practices in quality, teamwork, and statistical methods, promoting their use across the organization.

Principal Responsibilities

•    Partner with R&D, Regulatory Affairs, and Operations to support activities in product and process design such as process development, process validation, test method development and validation, fixture design and qualification, and ensure appropriate execution of necessary updates to design history files.
•    Maintain and update risk files consisting of but not limited to risk management plans, hazard and risk analyses, failure mode and effects analyses and risk management reports to assess the risks associated with a product.
•    Partner with operations quality engineers to ensure design controls and PFMEA to DFMEA & EDO linkages are maintained. Ensure proper implementation of process controls by reviewing production lines.
•    Develop and validate test methods. Identify and apply metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices. Conduct measurement system error studies such as Gage R&R.
•    Use quality tools and statistical techniques to determine sample sizes, collect and summarize data, determine data distributions, identify relationships between variables, design and analyze experiments, calculate reliability, determine process and performance capability, draw conclusions with confidence, and make statistically supported decisions.
•    Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented.
•    Understand applicable external regulations and internal standards that drive compliance and apply them in their daily function. Perform audits of Design History Files and support both internal and external audits.
•    Perform root cause analysis of identified issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.
•    Provide input on projects for supplier process improvement and process qualifications.  
 

Education / Experience Requirements

•    B.A. or B.S. degree in a technical discipline, such as engineering or science (equivalent experience may be considered). 
•    2 to 5 years of quality engineering or design assurance experience (preferably in the medical device industry).  
 

Specialized Skills / Other Requirements

•    ASQ certification preferred (e.g. CQE, CQA, CMDA, CRE, CSSGB/CSSBB). 
•    Basic understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820.
•    Proficient in MS Office, and Minitab or other statistical softwares.
•    Strong organizational and time management skills to meet deadlines while managing multiple projects.
•    Strong analytical and critical thinking skills.
•    Proficient in technical report writing and review.
•    Strong verbal and written communication skills. 
•    Foster a positive culture of growth, collaboration, and achievement across the organization.
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