Senior Quality Engineer - Manufacturing (Medical Devices)

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 and 10 holidays

Company-paid life insurance

401k plan

Pet Insurance

Home Ownership

Tuition Reimbursement

Job summary

Viant Medical in Wheeling, IL, seeks a Senior Quality Engineer to lead the design and manufacturing quality programs for medical device components and finished products. You’ll drive continuous improvement, CAPA investigations, and regulatory compliance with a deep focus on QMS, process validation, and cross‑functional collaboration.

Onsite daily with market-competitive compensation and a comprehensive benefits package.

Qualifications

• Bachelor’s degree in Engineering (Mechanical preferred) or related field.
• 7+ years of QA experience in a regulated manufacturing environment, medical devices ideal.
• Certifications: CQE/CRE/CQA or Six Sigma Green/Black Belt preferred.

Responsibilities

• Adhere to QMS and all safety and quality requirements.
• Support regulatory inspections, audits, investigations, and inquiries.
• Monitor manufacturing for compliance with DMR and quality systems.
• Identify, prioritize, and implement product and process improvement initiatives.
• Review changes to BOMs, assembly procedures, drawings, and specifications.
• Lead protocol and report generation for validations.
• Coordinate process validations and capability studies with Manufacturing Engineers.
• Develop inspection techniques and procedures for incoming, in-process, and final inspections.
• Ensure disposition of non-conforming materials and implement corrective actions.
• Lead complaint investigations and remediation activities.
• Review quality data for CAPAs and root-cause analyses.
• Assist with product transfers.
• Collaborate with suppliers and teams on problem resolution and SPC techniques.
• Provide guidance to Quality Inspectors, Technicians, and Engineers.

Skills

Root cause analysis

DOE

Statistics

Lean manufacturing

Risk management

Six Sigma

Microsoft Office

Minitab

Interpersonal communication

Cross-functional leadership

Education

Bachelor’s degree in Engineering

Tools

QMS Software

Job description

Viant Medical in Wheeling, IL, seeks a Senior Quality Engineer to lead the design and manufacturing quality programs for medical device components and finished products. You’ll drive continuous improvement, CAPA investigations, and regulatory compliance with a deep focus on QMS, process validation, and cross‑functional collaboration.

Onsite daily with market-competitive compensation and a comprehensive benefits package.