Quality Engineer, MedTech: Impact & Compliance

Viant Medical Inc.; Massachusetts; On-site; USD 70,000 - 95,000; Full time

Job summary

Viant Medical Inc. is seeking a Quality Engineer to provide support for Operations and ensure adherence to quality systems in medical device manufacturing. You will work to maintain regulatory compliance across design and production processes.

The role requires 2–5 years in a regulated manufacturing environment, strong communication skills, and proficiency with QMS tools and statistical methods. On-site work in Brimfield, MA with opportunities for growth.

Qualifications

• Bachelor’s degree in Engineering or related field required.
• 2–5 years of experience in quality engineering within a regulated industry.
• Strong knowledge of FDA/ISO quality systems and regulatory requirements.

Responsibilities

• Supports Quality Engineering for Operations to ensure QMS compliance.
• Assists with regulatory inspections, audits, and inquiries for design/manufacturing quality.
• Reviews changes to BOMs, drawings, and specifications and ensures proper documentation.
• Leads CAPA activities, data analysis, and root cause investigations.
• Coordinates with suppliers and internal teams on quality improvements and process validation.

Skills

Quality engineering

Regulatory knowledge

Strong communication

Statistical methods

Education

Bachelor’s Degree in Engineering

Tools

Microsoft Office

Minitab

Job description

Viant Medical Inc. is seeking a Quality Engineer to provide support for Operations and ensure adherence to quality systems in medical device manufacturing. You will work to maintain regulatory compliance across design and production processes.

The role requires 2–5 years in a regulated manufacturing environment, strong communication skills, and proficiency with QMS tools and statistical methods. On-site work in Brimfield, MA with opportunities for growth.