Quality Leader - Medical Devices & Compliance

Avalign Technologies; Akron (OH); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive pay

Benefits package

401(k) plan

Tuition reimbursement

Paid time off

Job summary

Avalign Technologies in Akron, OH seeks a seasoned Quality leader to oversee the Site Quality System, ensuring compliance with regulatory standards and customer requirements. You will coordinate audits, manage CAPA, and drive continuous improvement across manufacturing and product development.

As the site Management Representative, you will mentor teams, report on quality KPIs, and collaborate with regulatory affairs to align with ISO 13485, FDA, and other standards.

Qualifications

• Bachelor's degree in engineering or science required.
• Five or more years management experience in quality assurance and/or engineering preferred.
• Minimum of three years' experience in a medical device industry in quality.

Responsibilities

• Lead overall direction, coordination, and evaluation of quality employees at the site.
• Serve as site Management Representative for the site quality system.
• Lead regulatory audits (notified bodies, government audits) and customer audits to ensure compliance.

Skills

Quality leadership

Regulatory affairs

Audit management

CAPA management

Cross-functional leadership

Education

Bachelor's degree in engineering or science

Tools

Quality System (QMS)

Regulatory databases

Job description

Avalign Technologies in Akron, OH seeks a seasoned Quality leader to oversee the Site Quality System, ensuring compliance with regulatory standards and customer requirements. You will coordinate audits, manage CAPA, and drive continuous improvement across manufacturing and product development.

As the site Management Representative, you will mentor teams, report on quality KPIs, and collaborate with regulatory affairs to align with ISO 13485, FDA, and other standards.