Quality Engineer - Medical Device QA & Process Lead

Viant Medical Inc.; Northern (KY); Hybrid; USD 70,000 - 95,000; Full time

Benefits offered by this job

Full Medical, Dental & Vision on day 1

401(k) on first day

Generous PTO and 10 holidays

Growth opportunities

On-Demand Pay

Job summary

Viant Medical Inc. is hiring for a Quality Engineer to ensure QMS compliance in medical device manufacturing. You will support regulatory inspections, manage quality documentation, and drive process improvements.

The role requires 2–5 years in a regulated quality engineering environment and a bachelor’s degree in engineering or related fields. Travel and cross-functional collaboration are involved.

Qualifications

• Bachelor’s Degree in Engineering or related field required.
• 2–5 years of experience in a quality engineering role within a regulated industry.
• Experience in medical device manufacturing is preferred.

Responsibilities

• Adheres to QMS, EMS, FDA regulations and company procedures.
• Supports regulatory inspections, audits, investigations, and inquiries on quality control.
• Monitors manufacturing for compliance with DMR and maintains device history records.
• Leads and implements product and process improvement methodologies.
• Reviews changes to BOMs, assembly procedures, drawings, specs and FMEAs.
• Leads risk analysis completion and maintenance.
• Generates protocols and reports for test method validations.
• Interfaces with Manufacturing Engineers for process reviews and validations.
• Develops inspection techniques and procedures; writes inspection documentation.
• Ensures non-conforming material disposition meets regulatory requirements and CAPA.
• Communicates with customers effectively.
• Leads complaint investigations.
• Leads CAPA activities with data analysis and root-cause.
• Assists with product transfers.
• Collaborates with suppliers and engineers to resolve quality problems using SPC.
• Prepares Quality Plans for new product introductions.
• May provide direction to 3–5 Inspectors/Technicians.
• Supports other quality engineers.
• Performs other duties as required.

Skills

Quality Engineering

Regulatory compliance

Statistical methods

Documentation & QA

Communication skills

Microsoft Office

Education

Bachelor's Degree in Engineering or related field

Tools

Minitab

Job description

Viant Medical Inc. is hiring for a Quality Engineer to ensure QMS compliance in medical device manufacturing. You will support regulatory inspections, manage quality documentation, and drive process improvements.

The role requires 2–5 years in a regulated quality engineering environment and a bachelor’s degree in engineering or related fields. Travel and cross-functional collaboration are involved.