Staff Quality Engineer

4 days ago

Mason, Ohio, United States AtriCure Full time
About AtriCure

AtriCure, Inc. is a leading medical technology company that provides innovative solutions for the treatment of atrial fibrillation and related conditions. With a strong commitment to quality and patient safety, we are dedicated to improving the lives of millions of people worldwide.

Job Summary

We are seeking a highly skilled Staff Quality Engineer to join our team in Mason, OH. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our contract manufactured products and collaborating with cross-functional teams to drive quality improvements.

Key Responsibilities
  • Provide quality engineering support for products acquired as finished devices, collaborating with contract manufacturers, suppliers, and internal functions.
  • Oversee and coordinate ongoing activities from external and internal functions, including product qualification, process validation, and supplier change requests.
  • Drive correction and preventive activities, including managing non-conforming reports and supplier change requests.
  • Apply reasoning ability to determine appropriate responses to novel or controversial problems.
  • Support and prioritize projects, adapting to shifting priorities and working with minimal guidance from management.
  • Contribute to the development and implementation of quality system processes with manufacturers.
  • Mentor junior quality engineers in best practices, technical proficiency, and past experiences.
  • Assist with internal and external audits as necessary.
Requirements
  • Bachelor's degree in Manufacturing Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field.
  • 6 years of progressive experience as a Quality Engineer or a related role.
  • 6 years of experience in each of the following: sterile packaging of disposable medical devices, EO and Gamma sterilization validation and continuous monitoring, lean manufacturing tools, and inspection/testing.
  • 3 years of experience in each of the following: using MS Office tools for communication and analysis, reading technical specifications, and working with Contract Manufacturers of finished devices.
  • 2 years of experience in both of the following: working with GD&T and assessing capability and running hypothesis tests of industrial or manufacturing statistics.
  • Some experience in both of the following: FDA and ISO 13485 knowledge and assessing capability and running hypothesis tests of industrial or manufacturing statistics.
What We Offer

AtriCure offers a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. We are an equal employment opportunity/affirmative action employer and provide a drug-free workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with a disability, sexual orientation, gender identity, or any other characteristic protected by federal, state, or local law.

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