Quality Engineer

T45 Labs • Cleveland, OH

2d • $80,000 - $108,000 • Onsite

About The Position

Advanced NanoTherapies (ANT), a T45 Labs portfolio company, is a clinical-stage startup developing drug-coated balloon catheters to deliver therapy directly to the vessel wall and treat vascular disease. The Quality Engineer will support the design, development, and manufacturing of combination medical devices as part of a small, growing Quality team. This hands-on role works side by side with manufacturing in a fast-moving environment and is suited to a collaborative, entrepreneurial team player.

Requirements

• Bachelor’s degree in biomedical engineering or a related field.
• At least 3 years of Quality experience in a regulated industry.
• Hands-on experience performing and leading root cause investigations and CAPAs.
• Experience working within FDA, MDR, and ISO 13485 medical device regulations.
• Experience in a manufacturing or production environment.
• Excellent oral and written communication skills and strong critical-thinking ability.
• Collaborative team player who works well with people at every level of the company.
• Permanently authorized to work in the United States without current or future visa sponsorship.
• Currently residing within a reasonable commute, approximately 20 to 30 miles, of the Cleveland facility.

Nice To Haves

• Medical device experience.
• Internal or supplier audit experience.
• Experience with startup or early-stage companies.
• Quality certification, such as ASQ Certified Quality Engineer (CQE).

Responsibilities

• Lead quality improvement projects within the quality system and manufacturing process.
• Lead efforts to implement and maintain an electronic quality management system (eQMS).
• Lead investigations within the nonconformance (NCR), corrective and preventive action (CAPA), and complaint processes.
• Perform root cause analysis and verify the effectiveness of corrective actions.
• Review device history records for product release.
• Work hands-on with manufacturing to resolve quality issues.
• Perform occasional internal and/or supplier audits as necessary.
• Provide informal mentoring and clear, constructive feedback to help drive quality in a fast-paced manufacturing environment.
• Ensure high-quality work instructions, protocols, reports, standard operating procedures, and other quality-system documents.
• Communicate regularly with suppliers and testing facilities.

Benefits

• The total compensation package may include bonus opportunities, equity, and company-sponsored benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level