Quality Engineer III, Design Assurance

Position Summary

As a member of a cross-functional team, the Quality Engineer III, Design Assurance is responsible for quality throughout   design transfer and commercialization and sustaining projects. The Quality Engineer III, Design Assurance ensures that applicable elements of the Quality System and external standards are followed. As the voice of Quality, the Quality Engineer III, Design Assurance applies best-practice quality, team-based and statistical tools and techniques, and promotes the value and use of such tools throughout the organization.

Principal Responsibilities

•    Partner with cross-functional teams, including manufacturing, quality, regulatory, and R&D, to ensure that product design and manufacturing processes are fully compliant with quality standards and regulatory requirements during a manufacturing site transfer
•    Act as a liaison between design assurance subject matter experts and the manufacturing site team to ensure smooth communication and alignment during the site transfer process
•    Coordinate and support process validation activities (OQ/PQ) to ensure processes are fully validated in accordance with applicable standards and requirements
•    Partner with operations quality engineers to ensure design controls and PFMEA to DFMEA & EDO linkages are maintained. 
•    Review and approve process validation protocols and reports and other technical documentation associated with the manufacturing site transfer
•    Ensure compliance of all practices to the Quality Management System. Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented.
•    Assist with root cause analysis of identified issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.
•    Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
•    Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule.
 

Education / Experience Requirements

•    B.A. or B.S. degree in a technical discipline, such as engineering or science (equivalent experience may be considered). 
•    5 to 10 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). 
•    Strong 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 (English, proficiency in Spanish is preferred but not required). 
•    Foster a positive culture of growth, collaboration, and achievement across the organization.
 

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