Quality Assurance Engineer I – Medical Devices

Viant Medical Inc.; Fort Wayne (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

Viant Medical Inc. is seeking a Quality Engineer to support Operations in maintaining compliance with QMS, EMS, FDA regulations, and industry standards.

The role involves coordinating QA activities, CAPA, audits, and process improvements across manufacturing processes. The ideal candidate has a engineering background with hands-on experience in regulated manufacturing, strong communication, and proficiency with quality tools such as Minitab and MS Office.

Qualifications

• Bachelor's Degree in Engineering or related field; 2-5 years in a quality engineering role within a regulated industry.
• 0-2 years' experience in medical device or regulated manufacturing.

Responsibilities

• Adheres to Quality Management Systems (QMS), EMS, FDA regulations, and company policies.
• Supports regulatory inspections, audits, investigations, and inquiries on product design and manufacturing quality.
• Monitors manufacturing for compliance with DMR; provides deviation/waiver guidance and maintains Device History Records.
• Implements product and process improvement methodologies.
• Reviews changes to BOMs, assembly procedures, drawings, component specs, FMEAs, and control plans.
• Maintains risk analyses and completes test protocol/validation reports.
• Coordinates process validations and capability studies; advises on monitoring devices where applicable.
• Develops inspection techniques and procedures for Incoming, In-Process, and Final Inspection.
• Ensures disposition of non-conforming materials meets regulatory requirements and drives corrective actions.
• Communicates with customers; completes complaint investigations.
• Executes CAPA activities; analyzes data and trends in complaints, supplier quality, and root causes.
• Assists with product transfers; collaborates with suppliers and engineers to resolve quality problems.

Skills

Multitasking

Quality tools & techniques

Communication

Regulatory knowledge

MS Office

Education

Bachelor's degree in Engineering

Tools

Minitab

MS Office

Job description

Viant Medical Inc. is seeking a Quality Engineer to support Operations in maintaining compliance with QMS, EMS, FDA regulations, and industry standards.

The role involves coordinating QA activities, CAPA, audits, and process improvements across manufacturing processes. The ideal candidate has a engineering background with hands-on experience in regulated manufacturing, strong communication, and proficiency with quality tools such as Minitab and MS Office.