Quality Manager - Medical Device/ ISO 13485

Vonco Products, LLC; Burlington (WI); On-site; USD 110,000 - 140,000; Full time

Job summary

Vonco Products, LLC is seeking a hands-on Quality Manager to lead and continuously improve our ISO 13485 Quality Management System while supporting a fast-paced medical device packaging manufacturing operation. The role partners with Operations, Engineering, Supply Chain, and Customer Service to ensure compliance and drive continuous improvement.

The ideal candidate will balance strategic quality system oversight with day-to-day operational support, lead CAPA activities, and effectively

Qualifications

• Experience developing and maintaining a QMS under ISO 13485.
• Ability to lead CAPA programs and post-market quality processes.
• Strong cross-functional collaboration with Operations, Engineering, Supply Chain, and Customer Service.

Responsibilities

• Manage and maintain the ISO 13485 Quality Management System.
• Coordinate Management Review activities and present quality system performance metrics.
• Lead CAPA and nonconformance processes.
• Oversee supplier audits and supplier performance reviews.
• Support risk management and ISO 14971 compliance.
• Drive continuous improvement and quality culture.

Skills

ISO 13485

Regulatory compliance

Quality leadership

CAPA

Audits

Job description

Quality Manager | ISO 13485 Medical Device Manufacturing

We are seeking a hands-on Quality Manager who can lead and continuously improve our ISO 13485 Quality Management System while supporting a fast-paced medical device packaging manufacturing operation. This individual will serve as the site quality leader, partnering closely with Operations, Engineering, Supply Chain, and Customer Service to ensure compliance, drive continuous improvement, and maintain customer confidence.

The ideal candidate is a proactive quality leader with experience in medical devices, healthcare packaging, or other regulated manufacturing environments. They are comfortable balancing strategic quality system oversight with day-to-day operational support and can effectively influence cross-functional teams.

Basic Purpose and Function:

The Quality Manager is responsible for developing, implementing, maintaining, and continuously improving the organization’s Quality Management System (QMS) in accordance with ISO 13485, applicable regulatory requirements, customer requirements, and company objectives.

This position serves as the site’s management representative for the Quality Management System. It ensures that product realization activities, risk management processes, supplier controls, CAPA activities, and post-market quality processes effectively support the manufacture of safe and effective medical devices.

The Quality Manager partners closely with Operations, Engineering, Supply Chain, and Customer Service teams to ensure compliance while driving a culture of quality and continuous improvement.

Job Responsibilities:

Quality Management System (QMS)

• Manage and maintain the ISO 13485 Quality Management System.
• Ensure compliance with all applicable regulatory and customer requirements.
• Oversee document control and record retention processes.
• Coordinate Management Review activities and present quality system performance metrics.
• Ensure quality objectives are established, monitored, and achieved.
• Maintain inspection readiness and audit preparedness.

CAPA and Nonconformance Management

• Lead the Corrective and Preventive Action (CAPA) program.
• Ensure timely investigation and closure of quality issues.
• Facilitate root cause investigations.
• Monitor effectiveness of corrective actions.
• Manage nonconforming product processes and disposition activities.
• Ensure risk management activities comply with ISO 14971 requirements.
• Participate in risk assessments associated with products, processes, equipment, and suppliers.
• Support implementation of risk controls and verification of effectiveness.
• Ensure risk management files remain current and complete.

Validation and Quality Engineering Support

• Review and approve validation protocols and reports.
• Support process improvement and process capability initiatives.
• Ensure manufacturing changes are properly evaluated and validated.

Internal Audits and Regulatory Inspections

• Manage the internal audit program.
• Coordinate external audits, customer audits, certification audits, and regulatory inspections.
• Track audit findings through closure.

Supplier Quality Management

• Ensure supplier qualifications and monitoring programs meet ISO 13485 requirements.
• Manage supplier audits and supplier performance reviews.
• Oversee supplier corrective action requests (SCARs).
• Support supplier risk assessments and change management.

Customer Quality and Complaint Handling

• Manage customer complaint investigations.
• Ensure complaint‑handling processes meet applicable regulatory requirements.
• Analyze customer quality trends and implement improvement actions.
• Serve as primary escalation point for customer quality issues.

Training and Quality Culture

• Ensure employee training programs meet regulatory and quality requirements.
• Verify personnel competency for quality‑critical tasks.
• Promote quality awareness throughout the organization.
• Support continuous improvement initiatives across all departments.

Leadership Responsibilities

• Lead and develop Quality Specialists, Technicians, Auditors, and Inspectors.
• Establish departmental goals and objectives.
• Provide quality guidance to Operations, Engineering, and Customer Service.

Success Measures

• Successful maintenance of ISO 13485 certification
• Timely closure and effectiveness of CAPAs
• Reduction in customer complaints and internal quality issues
• Successful completion of internal, customer, and certification audits
• Supplier quality performance improvements
• On-time completion of Management Reviews and Quality Objectives

Description:

Quality Manager | ISO 13485 Medical Device Manufacturing

We are seeking a hands‑on Quality Manager who can lead and continuously improve our ISO 13485 Quality Management System while supporting a fast‑paced medical device packaging manufacturing operation. This individual will serve as the site quality leader, partnering closely with Operations, Engineering, Supply Chain, and Customer Service to ensure compliance, drive continuous improvement, and maintain customer confidence.

The ideal candidate is a proactive quality leader with experience in medical devices, healthcare packaging, or other regulated manufacturing environments. They are comfortable balancing strategic quality system oversight with day‑to‑day operational support and can effectively influence cross‑functional teams.

Basic Purpose and Function:

The Quality Manager is responsible for developing, implementing, maintaining, and continuously improving the organization’s Quality Management System (QMS) in accordance with ISO 13485, applicable regulatory requirements, customer requirements, and company objectives.

This position serves as the site’s management representative for the Quality Management System. It ensures that product realization activities, risk management processes, supplier controls, CAPA activities, and post‑market quality processes effectively support the manufacture of safe and effective medical devices.

The Quality Manager partners closely with Operations, Engineering, Supply Chain, and Customer Service teams to ensure compliance while driving a culture of quality and continuous improvement.

Job Responsibilities:

Quality Management System (QMS)

• Manage and maintain the ISO 13485 Quality Management System.
• Ensure compliance with all applicable regulatory and customer requirements.
• Oversee document control and record retention processes.
• Coordinate Management Review activities and present quality system performance metrics.
• Ensure quality objectives are established, monitored, and achieved.
• Maintain inspection readiness and audit preparedness.

CAPA and Noncon