ISO 13485 Quality Leader — Medical Devices

American Society for Quality; Northern (KY); Hybrid; USD 90,000 - 150,000; Full time

Job summary

American Society for Quality in Kentucky seeks a hands-on Quality Manager to lead the ISO 13485 QMS for a fast-paced medical device packaging operation. You will partner with Operations, Engineering, Supply Chain, and Customer Service to ensure regulatory compliance, drive continuous improvement, and maintain customer confidence.

The role blends strategic oversight with day-to-day quality activities, including CAPA, risk management, supplier qualification, and audit readiness.

Qualifications

• Bachelor’s degree or higher in a relevant field.
• 5+ years of progressive quality experience in a regulated manufacturing environment.
• 3+ years working with ISO 13485 Quality Management Systems.
• Experience leading internal, customer, and certification audits.
• Experience in CAPA, nonconformance, change control, complaint handling, and supplier quality.

Responsibilities

• Maintain the ISO 13485 Quality Management System and ensure regulatory compliance.
• Lead CAPA program and ensure timely investigation and closure of quality issues.
• Coordinate internal and external audits, certifications, and regulatory inspections.
• Oversee supplier qualification, audits, and supplier corrective actions (SCARs).
• Support risk management activities and validation of manufacturing changes.
• Promote quality culture and provide guidance to Operations, Engineering, and Customer Service.

Skills

Leadership

Regulatory knowledge

Cross-functional collaboration

Problem solving

Strategic planning

Education

Bachelor’s degree in engineering, Quality, Manufacturing, Life Sciences, or related field

Tools

ISO 13485

CAPA systems

Internal auditing

Risk management

Supplier qualification

Validation (IQ/OQ/PQ)

Complaint investigations

Document control

Job description

American Society for Quality in Kentucky seeks a hands-on Quality Manager to lead the ISO 13485 QMS for a fast-paced medical device packaging operation. You will partner with Operations, Engineering, Supply Chain, and Customer Service to ensure regulatory compliance, drive continuous improvement, and maintain customer confidence.

The role blends strategic oversight with day-to-day quality activities, including CAPA, risk management, supplier qualification, and audit readiness.