Quality Engineer, Medical Devices | On-Demand Pay & Growth

Viant Medical Inc.; Brimfield (MA); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental & Vision insurance

401(k)

Paid time off

Holidays

On-Demand Pay

Growth opportunities

Job summary

Viant Medical Inc. is seeking a Quality Engineer to support Operations by ensuring the Quality System requirements are met for medical device manufacturing and operations.

The role emphasizes compliance with FDA regulations and ISO 13485, while contributing to continuous improvement and risk management. You will collaborate with Manufacturing, Engineering, and Quality teams, lead CAPA activities, and participate in process validations and documentation control to ensure product quality from

Qualifications

• Bachelor’s degree in engineering or related field or 2–5 years in quality engineering in regulated industry.
• Experience with FDA regulations and ISO 13485 is preferred.
• Experience in medical device manufacturing quality systems.
• Strong communication and teamwork skills.

Responsibilities

• Adheres to safety and quality requirements including QMS, EMS, FDA regulations, company policies and procedures.
• Supports regulatory inspections, audits, investigations, and inquiries regarding design and manufacturing quality.
• Monitors manufacturing for compliance with DMR and maintains Device History Records.
• Leads product and process improvement methodologies and CAPA activities.

Skills

Quality engineering

Regulatory knowledge

Communication

CAPA & root cause

Documentation & records

Education

Bachelor’s Degree in Engineering or related field

Tools

Minitab

Microsoft Office

Job description

Viant Medical Inc. is seeking a Quality Engineer to support Operations by ensuring the Quality System requirements are met for medical device manufacturing and operations.

The role emphasizes compliance with FDA regulations and ISO 13485, while contributing to continuous improvement and risk management. You will collaborate with Manufacturing, Engineering, and Quality teams, lead CAPA activities, and participate in process validations and documentation control to ensure product quality from