Quality Engineer - Medical Device | CAPA & QC Lead (Onsite)

T45 Labs; Oklahoma; On-site; USD 80,000 - 108,000; Full time

Job summary

Advanced NanoTherapies, a T45 Labs portfolio company, seeks a Quality Engineer to support design, development, and manufacturing of next‑gen drug‑coated balloon catheters. You will lead investigations, review release documentation, and maintain the quality management system in a fast‑paced environment.

The role requires a bachelor’s in biomedical engineering, 3+ years in a regulated medical device setting, and strong root cause and CAPA skills.

Qualifications

• Bachelor’s degree in biomedical engineering or related field.
• 3+ years of quality experience in a regulated industry (medical devices preferred).
• Hands-on experience with root cause investigations and CAPAs.

Responsibilities

• Lead quality improvement projects within the quality system and manufacturing processes.
• Lead implementation and ongoing maintenance of an eQMS.
• Lead investigations in NCR, CAPA, and Complaint processes.

Skills

Quality Assurance

Root Cause Analysis

CAPA Investigations

Regulatory Compliance

Cross-functional Collaboration

Education

Bachelor's degree in Biomedical Engineering

Job description

Advanced NanoTherapies, a T45 Labs portfolio company, seeks a Quality Engineer to support design, development, and manufacturing of next‑gen drug‑coated balloon catheters. You will lead investigations, review release documentation, and maintain the quality management system in a fast‑paced environment.

The role requires a bachelor’s in biomedical engineering, 3+ years in a regulated medical device setting, and strong root cause and CAPA skills.