Sr. Quality Engineer, Design Assurance PMS

Position Summary

As a member of a cross-functional team, the Sr. Quality Engineer, Design Assurance is responsible for quality throughout new product development and improvement up to and including technology transfer and commercialization. The Sr. Quality Engineer, Design Assurance ensures that applicable elements of the Quality System and external standards are followed. As the voice of Quality, the Sr. 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, 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.
• Perform post-market surveillance collecting data periodically throughout a product’s lifecycle which will also be used to feed back into the product risk file in order to reflect its current risk profile.
• 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.
• Contribute to corporate technical programs (e.g., system improvement, remediation, harmonization) in areas related to those identified in this position description.
• Other duties as requested by supervisor.

Education / Experience Requirements

Specialized Skills / Other Requirements

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At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front. Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at : 877-880-8588 or Talent@Teleflex.com. Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and / or other countries.

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