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Medical Device Quality Engineer

Durham, NC
Amick Brown is seeking an experienced Quality Engineer  for our direct client.

Location : Durham, NC
Duration: 11 Months

Description:
  • The primary focus of this position to support design teams tasked with development and delivery of these products from a Product Quality perspective.
  • Our clients seeks a strong technical contributor who can lead cross functional teams in process development, help define practical, useful quality metrics and specifications, identify key opportunities for product and process improvement, launch quality initiatives, lead projects to implement these initiatives, and serve as an expert consultant to help solve the most technically challenging quality problems.
  • The ideal candidate possesses a broad base of experience and a high level of technical depth in at least two technical specialties applicable to medical robotics, and is equally at home in the test lab and providing technical leadership to our team as we develop standard practices of our organization.
  • You will not abide “process red tape”, instead passionately seeking the most efficient way to build in product quality.
  • And you will also coach, mentor, teach, and influence the engineering staff in best quality practices, data analysis, protocol development, and design for quality and reliability methods.
  • Help us powerfully drive our quality mission in our growing company by bringing your hands-on experience in solving tough engineering problems in a compliant way, your fascination with complex electro-mechanical devices, and your passion for the best practices to design, monitor, and improve product and process.
Roles & Responsibilities:
Problem Solving
  • Run complex problem solving efforts without oversight, and mentor others on best practices.
  • Use advanced Six Sigma tools. Introduce and drive the adoption of new tools and methods to the business. Apply strong analytic skills as proven by track record of analyzing and fixing complex problems.
Engineering
  • Understand Design Controls, Change Controls, Product Engineering processes, and Production process control methodologies in a medical device environment.
Quality Systems & Risk Management
  • Navigates quality system independent of oversight. Develops project plans including the proposed quality system risks & benefits. Makes updates to improve quality systems and mentor others. Analyzes RMAs, QNs and make the necessary updates to risk documents.
Compliance
  • Able to articulate the latest and complex regulation to project team. Able to understand the impact of regulations to our procedures and make the corresponding SOP/DOP updates. Able to contribute in external audits, perform internal audits.
  • Ability to influence others
  • Passionate about our mission to improve product quality. Able to use persuasive, logical arguments based on data. Assist people in finding creative compliant solutions which meet constraints. Lead by exampleA passion for doing the vital few things efficiently and well
  • A strong desire to make work fun
Required Skills:
  • Minimum Education- Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
  • Technical Expertise: 5+ years’ experience in Quality Engineering or related field, with at least 3 year in medical device manufacturing

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