Quality Engineer II

3 weeks ago

Laconia, United States Leddy Group Full time

A growing, steady company is looking for a skilled professional for their Quality Engineer II role in Laconia, NH. You’ll help ensure our client develops and produces high-quality medical devices that make a difference in people’s lives. This is a full-time, direct-hire opportunity with excellent benefits effective date of hire and a collaborative, fast-paced environment

  • Responsibilities of the Quality Engineer IIDesign and implement policies and procedures for testing and evaluating products/equipment for precision and accuracy
  • Provide direction, analysis, and recommendations for product development
  • Maintain company compliance with FDA regulations and ISO standards
  • Write training material and conduct training sessions on quality control activities
  • Participate in external/internal audits
  • Lead continuous improvement projects
  • Support both internal and external customers
  • Perform other related duties as required
  • Qualifications of the Quality Engineer II5-10 years of experience in the medical device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility
  • Quality Engineering certification (CQE) preferred, or equivalent body of knowledge (statistics, SPC, GD&T, sampling)
  • BS in engineering, a technical or scientific discipline, or additional experience in lieu of degree
  • 3+ years of project management experience, preferably supporting a diverse team
  • Experience with FDA and ISO 13485 Certification inspections is a plus
  • Computer proficiency including Microsoft Office, Minitab preferred
  • Experience with Lean Manufacturing and Six Sigma is a plus
  • Attention to detail and organizational skills
  • Excellent verbal and written communication, customer service, and interpersonal skills

Please share your resume in confidence for this Quality Engineer II role. We look forward to hearing from you

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