Onsite Quality Engineer - Medical Devices, CAPA Lead

T45 Labs; Cleveland (OH); 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 medical devices. You will lead investigations, review product for release, and maintain the quality management system in a fast-moving environment.

The role requires hands-on work with manufacturing, a collaborative mindset, and a drive to grow with the company. Onsite in Cleveland, Ohio, with a strong emphasis on regulatory compliance.

Qualifications

• Bachelor’s degree in biomedical engineering or related field.
• 3+ years of quality experience in regulated industry (medical device preferred).
• Hands-on experience with root cause investigations and CAPAs.
• Experience with FDA, MDR, and ISO 13485 regulations.
• Experience in manufacturing or production environment.
• Excellent oral and written communication and critical thinking.
• Collaborative team player.

Responsibilities

• Lead quality improvement projects within the quality system and manufacturing process.
• Lead quality efforts in implementation and maintenance within an eQMS.
• Lead investigation efforts within NCR, CAPA, and Complaint processes.
• Perform root cause analysis and verify corrective actions are effective.
• Review device history records for product release.
• Work hands-on with manufacturing to resolve quality issues.
• Perform occasional internal and/or supplier audits.
• Provide mentoring and constructive feedback to drive quality in a fast-paced environment.
• Ensure high-quality output of quality documents (WIs, protocols, reports, SOPs).
• Communicate regularly with suppliers and testing facilities.

Skills

Quality experience

Root cause analysis

CAPA

FDA MDR ISO 13485

Manufacturing environment

Communication skills

Team 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 medical devices. You will lead investigations, review product for release, and maintain the quality management system in a fast-moving environment.

The role requires hands-on work with manufacturing, a collaborative mindset, and a drive to grow with the company. Onsite in Cleveland, Ohio, with a strong emphasis on regulatory compliance.