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Quality Engineer

3 months ago

Arlington, United States TALENT Software Services Full time

Are you an experienced Quality Engineer with a desire to excel? If so, then Talent Software Services may have the job for you Our client is seeking an experienced Quality Engineer to work at their company in Maple Grove, MN.



Position Summary: The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. This role will work within high-performance, cross-functional teams to ensure safety, quality, and compliance of commercialized products while continuously improving their value through end-of-life. Design Assurance drives the ISO 14971 risk management process and the Verification & Validation (V&V) process. This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports. This role will be responsible for ensuring quality and compliance through product development and commercialization for medical electrical equipment/systems (MEE) within the Interventional Cardiology (IC) division. This person will be helping with sustainment of CAPA work and solutions - on development side.



Primary Responsibilities/Accountabilities:

  • Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
  • Act as an effective team member in supporting quality disciplines, decisions, and practices
  • Work within a cross-functional team to identify and implement effective controls and support commercial design changes, specifically with regard to quality and risk management
  • Support the verification, validation, and usability testing to meet or exceed internal and external requirements
  • Perform regulatory standard assessments and support regulatory submissions to notified bodies
  • Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
  • Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
  • Update and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)



Qualifications:

  • Bachelor's degree in biomedical, Mechanical, or Electrical Engineering, or related field of study
  • Plus 2+ years of experience in design assurance, new product development, or related experience in a highly regulated industry
  • Demonstrated use of Quality tools/methodologies
  • Strong verbal and written communication skills
  • Self-motivated with a passion for solving problems and a bias for action
  • Effectively work and collaborate in a hybrid (onsite plus remote) environment



Preferred:

  • Prior medical device industry experience, particularly with medical electrical equipment
  • Working knowledge of US and International regulations including ISO 13485, ISO 14971, IEC 60601-1, EN 62366, and Quality System Regulations
  • Experience in managing multiple projects across multiple organizational disciplines