Quality Engineer

Quality Engineer

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.

Roles & Responsibilities:

• 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.

Education & Experience:

• 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.