Quality Engineer 2, Design Assurance PMS

Position Summary

As a member of a cross-functional team, the Quality Engineer II, Design Assurance is responsible for quality throughout new product development (up to and including design transfer and commercialization) and sustaining projects. The Quality Engineer II, Design Assurance ensures that applicable elements of the Quality System and external standards are followed. As the voice of Quality, the Quality Engineer II, 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

•    Author and maintain post-market periodic safety update reports for Teleflex devices. 
•    Interface with key functional areas within Teleflex to obtain necessary information and documents required for the development and maintenance of post market documentation. 
•    Apply technical solutions to improve problem solving, data collection, and analysis to add efficiency and effectiveness to the post market process and the use of post market data in the ongoing risk management activities for supported products
•    Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process design such as design verification, design validation, design reviews, design 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.
•    Use appropriate quality tools and statistical techniques to collect and summarize data, draw conclusions with confidence, 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 cost of quality throughout the product’s lifecycle.
•    Ensure compliance of all practices to 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 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). 
•    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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