Quality Systems Engineer: Drive FDA/ISO Compliance

Amcor Flexibles, LLC; Franklin (IN); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Medical, dental and vision plans

Retirement Savings Plan with company m

Paid Parental Leave

Tuition Reimbursement

Job summary

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

Responsibilities include CAPA investigations, audit readiness, and regulatory compliance with FDA, GMP, ISO standards, while promoting a culture of quality and continuous improvement across

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or related technical discipline.
• 3+ years in a regulated healthcare manufacturing environment preferred.
• Working knowledge of Quality Management Systems and quality engineering principles.
• Experience with CAPA, nonconformance, change control, document control, and auditing processes.
• Knowledge of FDA regulations, GMP, and ISO standards.

Responsibilities

• Maintain and improve the site's Quality Management System in compliance with regulatory requirements.
• Develop, revise, and control quality system procedures, work instructions, forms, and records.
• Ensure QMS processes align with FDA regulations, ISO standards, and company policies.
• Lead CAPA investigations and monitor effectiveness with cross-functional teams.
• Coordinate internal and external quality audits and track corrective actions.

Skills

Analytical skills

Root cause analysis

Communication

Project management

Organizational skills

QMS software

CAPA experience

Education

Bachelor's degree in Engineering or Quality

Tools

QMS software

Microsoft Office

Job description

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

Responsibilities include CAPA investigations, audit readiness, and regulatory compliance with FDA, GMP, ISO standards, while promoting a culture of quality and continuous improvement across