Quality Engineer II - Validation & Sustaining

ICU Medical; Salt Lake City (UT); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading medical device company in Salt Lake City is seeking a Quality Engineer II to ensure that all manufacturing processes meet regulatory and quality standards. The successful candidate will develop validation protocols, conduct risk assessments, and maintain compliance with FDA regulations and ISO standards. A Bachelor’s degree in a STEM field and experience in a regulated environment are essential, alongside strong communication and organizational skills.

Qualifications

• 2-4 years’ experience in regulated manufacturing or healthcare environment.
• Prior experience in quality is preferred.
• Strong knowledge of medical device validation processes.

Responsibilities

• Ensure that manufacturing processes meet quality standards.
• Develop and execute validation protocols for equipment and software.
• Conduct risk assessments for critical quality attributes.

Skills

Agile PLM / Oracle

Geometric Dimensioning & Tolerancing (GD&T)

Minitab

Microsoft Office Suite

Strong communication skills

Multitasking

Attention to detail

Organizational skills

Education

Bachelor's degree in STEM

Tools

Validation software

Statistical analysis software

Job description

A leading medical device company in Salt Lake City is seeking a Quality Engineer II to ensure that all manufacturing processes meet regulatory and quality standards. The successful candidate will develop validation protocols, conduct risk assessments, and maintain compliance with FDA regulations and ISO standards. A Bachelor’s degree in a STEM field and experience in a regulated environment are essential, alongside strong communication and organizational skills.