Quality Engineer 2, Design Assurance

Position Summary

As a member of a cross-functional team, the Quality Engineer, Design Assurance is responsible for quality throughout new product development and improvement up to and including technology transfer and commercialization. The Quality Engineer, Design Assurance ensures that applicable elements of the Quality System and external standards are followed. As the voice of Quality, the Quality Engineer, 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 R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process design, such as design verification, validation, reviews, transfer, and all other aspects of a design history file.
•    Create and maintain 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.
•    Analyze post-market surveillance data periodically throughout a product’s lifecycle to feed back into its risk file to reflect its current risk profile. Support Clinical and Medical Writers in analyzing available clinical data, as required.
•    Use appropriate quality tools and statistical techniques to collect and summarize data, draw confident conclusions, determine sample sizes, apply data distributions, identify relationships between variables, calculate reliability, design and analyze experiments, determine process and performance capability, and make statistically supported decisions.
•    Apply the most relevant and useful quality philosophies throughout Design Control and its related processes for both new product development and sustaining. Understand and manage work to minimize the cost of quality throughout the product’s lifecycle.
•    Ensure compliance of all practices with the Quality Management System. Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented.
•    Interpret customer feedback to define user needs and product requirements as part of a cross-functional team.
•    Partner with Product Quality Assurance and Operations to make risk-based decisions associated with nonconformances and technical complaints.
•    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.
•    Partner with Human Factors SMEs and R&D to assess the usability of a device throughout design and development.
•    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.
•    Perform root cause analysis of identified issues and identify appropriate corrective and preventive actions. Use the NC and CAPA systems as needed to structure activities.
•    Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
•    Define, identify, and apply product and process control methods such as developing control plans, identifying essential design outputs and critical control points, and developing and validating work instructions.
•    Apply the concepts of producer and consumer risk and related terms, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc. Interpret and select variable, attribute, and zero-defect sampling plans.
•    Apply supplier management principles and provide input on projects for supplier selection, quality expectation letters, supplier quality agreements, and process qualifications.
•    Partner with the PMO to apply project management tools to define project deliverables and establish a project schedule.
•    Generally apply the above concepts as required at the local and departmental level.

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 software.
•    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.