Quality Systems Engineer: Healthcare QMS & CAPA Lead

amcor; Franklin (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Amcor is seeking a Quality Systems Engineer to develop, implement, and maintain the Quality Management System within a regulated healthcare manufacturing environment. You will ensure compliance with FDA and ISO standards while partnering with manufacturing, engineering, supply chain, and validation teams to drive continual improvement and maintain inspection readiness.

You will lead CAPA investigations, support audits, and manage change control, document control, and quality system improvements.

Qualifications

• Bachelor's degree in Engineering or related field.
• 3+ years in regulated healthcare manufacturing.
• Knowledge of Quality Management Systems and quality engineering.
• Experience with CAPA, nonconformance, change control, document control, and audits.
• Familiarity with FDA regulations and GMP requirements.

Responsibilities

• Maintain and improve the Quality Management System per regulatory requirements.
• Lead CAPA investigations and track effectiveness.
• Plan and conduct internal quality audits and support supplier/customer audits.
• Monitor regulatory changes and update processes.
• Drive continuous improvement with data-driven methods.

Skills

CAPA

Nonconformance management

Change control

Document control

Auditing

Quality systems knowledge

Education

Bachelor's degree in Engineering or related

Job description

Amcor is seeking a Quality Systems Engineer to develop, implement, and maintain the Quality Management System within a regulated healthcare manufacturing environment. You will ensure compliance with FDA and ISO standards while partnering with manufacturing, engineering, supply chain, and validation teams to drive continual improvement and maintain inspection readiness.

You will lead CAPA investigations, support audits, and manage change control, document control, and quality system improvements.