Lead Quality Engineer – Med Device Design & Risk (Onsite)

INFOSYS NOVA HOLDINGS LLC; Salt Lake City (UT); On-site; USD 85,000 - 120,000; Full time

Job summary

Kaleidoscope, an Infosys Company, is seeking a Quality Engineer in Salt Lake City, UT. The role focuses on leading quality activities, design controls, risk management, and process improvements within product development teams.

The ideal candidate will have 7–9 years of experience in quality systems for medical devices, expertise with ISO 13485/14971 and 21 CFR 820, and strong analytical and documentation skills to support compliance and continuous improvement.

Qualifications

• Bachelor’s degree in Engineering or related field is required.
• Experience with Quality Management Systems in medical device development.
• Experience with ISO 13485, ISO 14971 and 21 CFR 820.
• Experience with statistical analysis preferred.

Responsibilities

• Lead cross‑department collaboration and serve as SME for quality in product development.
• Develop and approve design controls, risk assessments, and V&V plans.
• Support Quality Management System conformance and drive corrective actions.

Skills

Quality Management

Documentation

Cross-department collaboration

Statistical analysis

MS Office

Attention to detail

Independent work

Education

Bachelor’s degree in Engineering or related field

Tools

ISO 13485

ISO 14971

21 CFR 820

Job description

Kaleidoscope, an Infosys Company, is seeking a Quality Engineer in Salt Lake City, UT. The role focuses on leading quality activities, design controls, risk management, and process improvements within product development teams.

The ideal candidate will have 7–9 years of experience in quality systems for medical devices, expertise with ISO 13485/14971 and 21 CFR 820, and strong analytical and documentation skills to support compliance and continuous improvement.