Senior Quality Engineer: Medical Device Manufacturing

Viant Medical; Wheeling (IL); On-site; USD 95,000 - 115,000; Full time

Benefits offered by this job

Medical, Dental, and Vision benefits

136 Hours PTO (prorated) & 10 paid H0l

Company-paid life insurance

401k plan

Pet Insurance

Home Ownership

Tuition Reimbursement

Job summary

Viant Medical in Wheeling, IL is seeking a Senior Quality Engineer to drive quality systems and regulatory compliance across design and manufacturing. You will lead process improvements, develop inspection methods, and coordinate validations to ensure product quality and CAPA execution.

The role requires 7+ years in regulated manufacturing, with expertise in QMS, DOE, statistics, Six Sigma, and cross-functional collaboration.

Qualifications

• Minimum 7+ years of Quality Assurance experience in a regulated manufacturing environment.
• Experience in medical devices or other regulated industries is preferred.
• Strong root cause analysis, DOE, statistics, lean manufacturing, risk management, and Six Sigma methods.
• Familiarity with Quality Management System (QMS), CAPA, and regulatory inspections.

Responsibilities

• Adhere to Quality Management System (QMS) and safety/quality requirements.
• Support regulatory inspections, audits, investigations and inquiries.
• Monitor manufacturing and ensure Device History Records are complete and compliant.
• Identify, prioritize and implement product and process improvements.
• Lead validation protocols and reports for product, process and test methods.
• Develop inspection techniques and write incoming, in-process and final inspection procedures.
• Coordinate with Manufacturing Engineers on validations and capability studies.

Skills

Root cause analysis

DOE

Statistics

Lean manufacturing

Risk management

Six Sigma methodologies

Communication

Cross-functional teams

Project management

Education

Bachelor's degree in Engineering

Tools

Minitab

Microsoft Office

Job description

Viant Medical in Wheeling, IL is seeking a Senior Quality Engineer to drive quality systems and regulatory compliance across design and manufacturing. You will lead process improvements, develop inspection methods, and coordinate validations to ensure product quality and CAPA execution.

The role requires 7+ years in regulated manufacturing, with expertise in QMS, DOE, statistics, Six Sigma, and cross-functional collaboration.