Quality Leader, ISO 13485 for Medical Devices

Vonco Products, LLC; Burlington (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Vonco Products, LLC in Wisconsin is seeking a hands-on Quality Manager to lead our ISO 13485 quality system in a fast-paced medical device packaging facility. You will partner with Operations, Engineering, Supply Chain, and Customer Service to ensure regulatory compliance, drive continuous improvement, and maintain customer confidence across all product realizations.

The ideal candidate will balance strategic system oversight with day-to-day operational support and lead a team of quality

Qualifications

• Bachelor's degree in engineering, quality, manufacturing, life sciences, or a related field.
• 5+ years of progressive quality experience in a regulated manufacturing environment.
• Experience in ISO 13485 Quality Management Systems.
• Experience leading internal, customer, and certification audits.
• Strong knowledge of CAPA, nonconformance, change control, and supplier quality.
• FDA-regulated manufacturing experience preferred.

Responsibilities

• Manage and maintain the ISO 13485 Quality Management System.
• Ensure regulatory and customer requirements compliance.
• Oversee document control and record retention.
• Coordinate management reviews and present quality metrics.
• Lead CAPA program and investigate quality issues.
• Manage supplier quality and supplier audits.
• Oversee risk management activities per ISO 14971.
• Coordinate internal and external audits and inspections.
• Provide quality guidance to Operations, Engineering, and Customer Service.

Skills

Quality leadership

Regulatory compliance

Cross-functional collaboration

CAPA management

Root cause analysis

Documentation

Education

Bachelor’s degree in engineering, quality, manufacturing, life sciences, or related field

Tools

ISO 13485

CAPA systems

Internal auditing

Risk management (ISO 14971)

IQ/OQ/PQ

Job description

Vonco Products, LLC in Wisconsin is seeking a hands-on Quality Manager to lead our ISO 13485 quality system in a fast-paced medical device packaging facility. You will partner with Operations, Engineering, Supply Chain, and Customer Service to ensure regulatory compliance, drive continuous improvement, and maintain customer confidence across all product realizations.

The ideal candidate will balance strategic system oversight with day-to-day operational support and lead a team of quality