Senior Quality Engineer – Medical Devices & Process Improvement

Viant Medical Inc.; Wheeling, Northern (IL, KY); Hybrid; USD 95,000 - 115,000; Full time

Benefits offered by this job

Medical, Dental, Vision

PTO 136 hours & 10 holidays

Company-paid life insurance

401k plan

Pet Insurance

Home Ownership

Tuition Reimbursement

Job summary

Viant Medical Inc. seeks a Senior Quality Engineer to ensure product quality and regulatory compliance throughout design and manufacturing of medical device components and finished products.

The role emphasizes QMS, process improvement, and cross-functional collaboration within a regulated environment. The ideal candidate brings deep expertise in quality systems and statistical methods, with a track record of leading CAPAs, inspections, and supplier quality initiatives.

Qualifications

• Bachelor's degree in Engineering or related discipline required.
• Minimum 7+ years of QA experience in regulated manufacturing environment.
• Experience with medical devices or regulated industry preferred.
• Strong knowledge of quality systems and regulatory compliance.

Responsibilities

• Adhere to QMS and safety/quality requirements across design and manufacturing.
• Support regulatory inspections, audits, investigations, and inquiries.
• Monitor manufacturing for compliance with DMR and QA systems; maintain device history records.
• Identify and drive product and process improvement initiatives.
• Review changes to BOMs, assembly procedures, drawings, specs, FMEAs, and control plans.
• Lead protocols and reports for product/process/test method validations.
• Collaborate with Manufacturing Engineers on process validations and capability studies.
• Develop inspection techniques and write/implement Incoming, In-Process, and Final Inspection procedures.
• Ensure proper disposition of non-conforming materials and execute corrective actions.
• Lead complaint investigations and remediation activities.
• Review QA data for CAPA candidates and root-cause analyses.
• Assist with product transfers and supplier quality improvements.
• Support SPC, DOE, Hypothesis Testing in quality problems.

Skills

Root cause analysis

DOE

Statistics

Lean manufacturing

Risk management

Six Sigma

Microsoft Office

Minitab

Education

Bachelor’s degree in Engineering (Mechanical preferred)

Tools

Minitab

Job description

Viant Medical Inc. seeks a Senior Quality Engineer to ensure product quality and regulatory compliance throughout design and manufacturing of medical device components and finished products.

The role emphasizes QMS, process improvement, and cross-functional collaboration within a regulated environment. The ideal candidate brings deep expertise in quality systems and statistical methods, with a track record of leading CAPAs, inspections, and supplier quality initiatives.