Quality Systems Engineer – Healthcare GMP & CAPA Leader

Amcor LLC; Franklin (IN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical, dental and vision plans

Flexible time off

Company-paid holidays

Wellbeing program & EAP

Retirement plan with company match

Tuition reimbursement

Discretionary annual bonus

Job summary

Amcor is seeking a Quality Systems Engineer to develop, implement, and continually improve the QMS in a regulated healthcare manufacturing environment. You will partner with Manufacturing, Engineering, Supply Chain, and Validation teams to drive improvements and ensure inspection readiness.

Responsibilities include maintaining procedures, conducting internal audits, supporting regulatory inspections, and leading risk-based continuous improvement initiatives across sites.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or related technical discipline.
• 3+ years of experience in a regulated healthcare manufacturing environment preferred.
• Knowledge of FDA regulations, GMP requirements, and ISO standards.
• Experience with CAPA, nonconformance management, change control, document control, and auditing processes.
• Strong analytical, problem-solving, and root cause investigation skills.

Responsibilities

• Maintain and improve the site's Quality Management System in compliance with applicable regulatory and industry requirements.
• Develop, revise, and control quality system procedures, work instructions, forms, and records.
• Facilitate CAPA investigations and monitor effectiveness with cross-functional teams.
• Plan, coordinate, and conduct internal quality system audits and support regulatory inspections.
• Lead risk management activities and drive continuous improvements in quality performance.
• Collaborate with Supplier Quality and Operations to address quality concerns.

Skills

QMS knowledge

CAPA

Root cause analysis

Auditing

Regulatory compliance

Project management

Problem solving

Communication

Education

Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or related technical discipline

Tools

QMS software

Statistical tools (e.g., Minitab)

Job description

Amcor is seeking a Quality Systems Engineer to develop, implement, and continually improve the QMS in a regulated healthcare manufacturing environment. You will partner with Manufacturing, Engineering, Supply Chain, and Validation teams to drive improvements and ensure inspection readiness.

Responsibilities include maintaining procedures, conducting internal audits, supporting regulatory inspections, and leading risk-based continuous improvement initiatives across sites.