Quality Manager, ISO 13485 | Medical Device Packaging

Vonco Products, LLC; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Vonco Products, LLC in Kentucky is seeking a hands-on Quality Manager to lead our ISO 13485 Quality Management System within a fast-paced medical device packaging operation. You will partner with Operations, Engineering, Supply Chain and Customer Service to ensure compliance, drive continuous improvement, and maintain customer confidence.

The role blends strategic quality oversight with day-to-day support, overseeing CAPA, internal audits, supplier quality, risk management, and validation

Qualifications

• Bachelor's degree in engineering or related field.
• 5+ years of progressive quality experience in regulated manufacturing.
• 3+ years working with ISO 13485 QMS.
• Experience leading internal, customer, and certification audits.
• Strong knowledge of CAPA, nonconformance, change control, and supplier quality.
• Experience in FDA-regulated manufacturing is highly preferred.

Responsibilities

• Lead and maintain the ISO 13485 Quality Management System.
• Ensure compliance with regulatory and customer requirements.
• Oversee document control and record retention processes.
• Coordinate Management Review activities and present quality metrics.
• Lead CAPA and nonconformance management and root-cause analysis.
• Manage supplier quality, SCARs, and supplier audits.
• Support risk management activities and validation efforts.
• Drive quality culture and training across departments.

Skills

ISO 13485

CAPA

Internal Audits

Risk Management

Quality Leadership

Regulatory Compliance

Education

Bachelor's degree in engineering

Job description

Vonco Products, LLC in Kentucky is seeking a hands-on Quality Manager to lead our ISO 13485 Quality Management System within a fast-paced medical device packaging operation. You will partner with Operations, Engineering, Supply Chain and Customer Service to ensure compliance, drive continuous improvement, and maintain customer confidence.

The role blends strategic quality oversight with day-to-day support, overseeing CAPA, internal audits, supplier quality, risk management, and validation