Quality Engineer

T45 Labs•Cleveland, OH

1d•Onsite

About The Position

Advanced NanoTherapies (ANT), a T45 Labs portfolio company, is a clinical-stage startup developing drug-coated balloon catheters to 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. The role includes leading investigations, reviewing products for release, and maintaining and improving the quality management system. It is hands-on and requires close daily collaboration with manufacturing in a fast-moving environment. The position is onsite at Advanced NanoTherapies’ facility in Cleveland, Ohio. Applicants should currently live within a reasonable commute, approximately 20 to 30 miles from the office; relocation assistance is not available. Candidates must be permanently authorized to work in the United States without current or future visa sponsorship. The anticipated hiring pay range is $80,000–$108,000 annually. Compensation is based on experience, qualifications, geographic location, and other job-related factors. The total compensation package may also include bonus opportunities, equity, and company-sponsored benefits.

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 skills.
Collaborative team player able to work well with people at every level of the company.
Permanently authorized to work in the United States without the need for current or future visa sponsorship.
Currently reside within a reasonable commute, approximately 20 to 30 miles, of the Cleveland office.

Nice To Haves

Medical device experience; it is preferred but not required.
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 implementation and ongoing maintenance of an electronic quality management system (eQMS).
Lead investigations through 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 needed.
Provide informal mentoring and clear, constructive feedback to support quality in a fast-paced manufacturing environment.
Ensure high-quality work instructions, protocols, reports, standard operating procedures, and other quality documents that support the quality system.
Communicate regularly with suppliers and testing facilities.