Quality Engineer

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

QUALITY ENGINEER

Company: Advanced NanoTherapies (ANT)

Type: Full-time

Location: Cleveland, Ohio - Onsite

Reports to: Sr. Quality Assurance Manager

ABOUT ADVANCED NANOTHERAPIES

Advanced NanoTherapies, a T45 Labs portfolio company, is a clinical-stage startup developing the next generation of drug-coated balloon catheters, designed to deliver therapy directly to the vessel wall, to treat vascular disease. Our team is dedicated to developing technologies that will change the medical device landscape. If you are seeking an opportunity to make a real impact on patients’ lives and grow your career, Advanced NanoTherapies is the right place for you.

ABOUT THE ROLE

We are seeking a highly motivated Quality Engineer to support the design, development, and manufacturing of our groundbreaking combination medical devices. As a member of our small, growing Quality team, you will lead investigations, review product for release, and perform tasks to maintain and improve the quality management system. . The position is hands‑on and requires the ability to be productive in a fast‑moving environment, working side by side with manufacturing every day. A successful candidate will be a team player with an entrepreneurial drive to grow with our company.

WHAT YOU WILL DO

• Lead the quality improvement projects within the quality system and manufacturing process.
• Lead quality efforts in implementation and continued maintenance within an eQMS.
• Lead investigation efforts within the NCR, CAPA, and Complaint processes.
• Perform root cause analysis and verify that corrective actions are effective.
• Review device history records for product release.
• Work hands‑on with the manufacturing team to resolve quality issues.
• Perform occasional internal and/or supplier audits as necessary.
• Be a go‑to partner for the team, offering informal mentoring and giving clear, constructive feedback to drive quality within a fast‑paced manufacturing environment.
• Ensure high quality output of work instructions, protocols, reports, SOPs, and other quality documents that support the quality system.
• Communicate regularly with suppliers and testing facilities.

WHAT YOU BRING

Required

• Bachelor’s degree in biomedical engineering or a related field.
• 3 or more years of Quality experience in a regulated industry. Medical device experience is preferred but not required.
• 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.
• A collaborative team player who works well with people at every level of the company.

Preferred

• Internal or supplier audit experience.
• Experience with startup or early‑stage companies is a plus.
• Quality certification, such as ASQ Certified Quality Engineer (CQE), is a plus.

ELIGIBILITY

Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor employment visas or permanent residency applications.

LOCATION AND COMPENSATION

This is an onsite position based at Advanced NanoTherapies’ facility in Cleveland, Ohio. The position is open to candidates who currently reside within a reasonable commute (approximately 20 to 30 miles) of our office. Relocation assistance is not available for this position.

The anticipated hiring pay range for this position $80,000 - $108,000 annually. Actual compensation will be determined based on experience, qualifications, geographic location, and other job‑related factors. Advanced NanoTherapies is committed to fair and equitable pay practices. The total compensation package may also include bonus opportunities, equity, and company‑sponsored benefits.

EQUAL OPPORTUNITY

Advanced NanoTherapies is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.