QMS & Compliance Lead — ISO 13485

ADDEV Materials Healthcare; Menomonee Falls (WI); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

PTO

Paid holidays

Job summary

ATL Corp is seeking a Quality Manager to lead the Quality Management System and ensure compliance with ISO 13485 and customer specifications. This role drives quality improvement initiatives, oversees quality assurance activities, and provides technical leadership across quality-related functions.

The ideal candidate has over 5 years of experience, strong knowledge of regulatory requirements, and excellent communication skills. The role is based in Menomonee Falls, Wisconsin and offers a competitive benefits package.

Qualifications

• 5+ years of quality experience in a regulated manufacturing environment.
• Strong knowledge of ISO 13485 and its application within a supplier environment.
• Excellent communication skills with ability to interface directly with customers and regulatory auditors.

Responsibilities

• Lead the Quality Management System (QMS) initiatives and improvement activities.
• Oversee compliance with ISO 13485 and regulatory specifications.
• Supervise, train, and develop the quality team.

Skills

Quality system management

Risk management

Regulatory compliance

Data analysis

Communication

Team Leadership

Tools

Microsoft Office

ERP/QMS software

Job description

ATL Corp is seeking a Quality Manager to lead the Quality Management System and ensure compliance with ISO 13485 and customer specifications. This role drives quality improvement initiatives, oversees quality assurance activities, and provides technical leadership across quality-related functions.

The ideal candidate has over 5 years of experience, strong knowledge of regulatory requirements, and excellent communication skills. The role is based in Menomonee Falls, Wisconsin and offers a competitive benefits package.