Quality Engineer

Job Summary:

• Seeking a Quality Engineer with 5+ years of experience in the medical device industry to support process verifications/validations, design quality engineering, design controls, risk management, and quality systems.
• The ideal candidate should have strong problem-solving, collaboration, and project leadership skills, with experience in Design/Process FMEA and product testing.

• Conduct Process Verifications/Validations.
• Perform Design and/or Process Failure Modes and Effects Analysis (FMEA).
• Perform blueprint reading, inspection methods, and GD&T.
• Ensure smooth implementation by working with the onsite team and managing project priorities.
• Collaborate with senior leadership on long-term strategy for the area/site.
• Perform risk management and execute product testing.
• Work on Quality Systems, including CAPA, nonconforming materials, risk management, and medical device regulations.
• Communicate effectively in both written and verbal formats and utilize Microsoft Word, Excel, and Outlook.

• 5+ years of work experience in the medical device industry.
• Experience conducting Process Verifications/Validations.
• Experience conducting Design and/or Process Failure Modes and Effects Analysis (FMEA).
• Design Quality Engineering experience.
• Design Control experience.
• Excellent problem-solving and decision-making skills.
• Strong interpersonal, collaboration, initiative, and project leadership skills.
  • Advanced degree.
  • Bachelor's degree in Mechanical Engineering or Bioengineering.
  • New Product Development experience.
  • Experience with blueprint reading, inspection methods, and GD&T.
  • Strong experience with Design Excellence, Six Sigma, or Lean.
  • Spanish as a second language.