Quality Engineer

Teleflex

(Morrisville, North Carolina)
Full Time
Job Posting Details
About Teleflex
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care.
Summary
Provide design assurance support in the development of new products and facilitate application of design control, create and maintain risk management files.
Responsibilities
* Lead Design Assurance activities and provide appropriate engineering/technical assessments supporting the design history file * Maintain the Risk Management Files – produce risk management documentation (DFMEA, PFMEA, Hazards Analysis, Risk Management Plans and Risk Management Reports) in accordance with internal procedures, applicable quality system, and external regulations and standards * Author Post Production Risk Assessments, Post Launch Market review, and Health Hazard Evaluations * Provide guidance to internal customers for Design Control, Development of test methods, Test protocols, Critical criteria, Establishing initial project deliverables, etc. * Participate in design reviews , design transfer process, and support design verification & validation activities * Suggest sound techniques to solve problems and make design/process improvement recommendations * Champion compliance to applicable standards * Coordinate Purchased Finished Good Specifications development between various internal customers * Provide written and oral reports to supervisor or other management personnel to keep them informed of activities and results. * Adhere to and ensure the compliance of all Company policies, rules, procedures and housekeeping standards. * As requested, provide risk management information for Management Reviews and other
Ideal Candidate
**Education / Experience Requirements:** * Bachelor’s Degree in Engineering (Mechanical, Industrial, Biomedical etc.) * Master’s Degree Preferred **Specialized Skills & Other Requirements:** * Knowledge of Statistical Analyses and Statistical software preferred * Knowledge of SolidWorks Preferred * MS Office * Good verbal and written communication skills to promote synergies between varioius departments * Working knowledge of ISO 14971, ISO 13485

Questions

Answered by on
This question has not been answered
Answered by on

There are no answered questions, sign up or login to ask a question

Want to see jobs that are matched to you?

DreamHire recommends you jobs that fit your
skills, experiences, career goals, and more.