Senior Quality Engineer: Validation & Sustaining

ICU Medical; Salt Lake City (UT); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device company is seeking a Senior Quality Engineer to provide technical quality engineering support in Salt Lake City. The role involves enhancing quality performance and ensuring compliance with industry regulations. Candidates should have a Bachelor's degree in engineering, over 7 years of experience, and a strong knowledge of FDA regulations. The position offers opportunities for continuous improvement and project management, along with a collaborative team environment.

Qualifications

• 7+ years of experience in quality engineering or related fields.
• Strong knowledge of FDA regulatory requirements.
• Experience in technical writing of documents in regulated industries.

Responsibilities

• Provide technical quality engineering support for quality assurance.
• Implement quality engineering tools for process improvements.
• Develop and execute validation protocols for manufacturing equipment.

Skills

Quality toolbox including six sigma methodology

Lean principles

Advanced statistics

Excellent communication skills

Organizational skills

Creative problem solver

Education

Bachelor’s degree in relevant engineering field

CQE Certification

Tools

Microsoft Office (Excel, Word)

Statistical analysis programs (Minitab)

Job description

A leading medical device company is seeking a Senior Quality Engineer to provide technical quality engineering support in Salt Lake City. The role involves enhancing quality performance and ensuring compliance with industry regulations. Candidates should have a Bachelor's degree in engineering, over 7 years of experience, and a strong knowledge of FDA regulations. The position offers opportunities for continuous improvement and project management, along with a collaborative team environment.