Quality Systems Engineer

Accelerate the possible by joining a winning Amcor team that's transforming the packaging industry and improving lives around the world.

At Amcor, we unpack possibility through our innovative and responsible packaging to provide solutions that benefit our customers, our people and our planet. More than 10,000 consumers worldwide encounter our products every second and rely on us for safe access to food, medicine and other goods. We value their trust by making safety our guiding principle. It's our core value and integral to how we do business.

Beyond this core principle, our shared values and behaviors unite us as we work together to elevate customers, shape lives and protect the future. We champion our customers and help them succeed. We play to win - adapting quickly in an ever changing world - and make smart choices to safeguard our business, our communities and the people we serve for generations to come.

And we invest in our world-class team, empowering our colleagues to unpack their potential, because we believe when our people grow, so does our business.

To learn more about playing for Team Amcor, visitwww.amcor.comILinked

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The Quality Systems Engineer is responsible for developing, implementing, maintaining, and continuously improving the Quality Management System (QMS) within a regulated healthcare manufacturing environment. This position ensures compliance with applicable regulatory requirements, industry standards, and company quality policies while supporting operational excellence and product quality. The Quality Systems Engineer partners closely with Manufacturing, Engineering, Supply Chain, and Validation teams to drive continual improvement initiatives and maintain inspection readiness.

• 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.
• Ensure QMS processes align with FDA regulations, ISO standards, and company quality policies.
• Support quality system harmonization and standardization initiatives across multiple manufacturing sites.

• Facilitate Corrective and Preventive Action (CAPA) investigations and ensure effective root cause analysis.
• Monitor CAPA effectiveness and timeliness through established metrics.
• Lead cross-functional teams in identifying and implementing sustainable corrective actions.
• Ensure compliance with CAPA procedures and regulatory expectations.

• Plan, coordinate, and conduct internal quality system audits.
• Support customer, supplier, regulatory, and certification audits.
• Prepare audit reports and track corrective actions to completion.
• Drive continuous audit readiness across the facility.

• Support compliance with FDA Quality System Regulation, ISO 9001, GMP, and other applicable healthcare regulations.
• Monitor changes in regulatory requirements and recommend updates to quality processes.
• Participate in regulatory inspections and customer assessments.
• Assist with responses to inspection observations and audit findings.

• Lead investigations of quality issues, nonconformances, and process deviations.
• Apply risk management principles to evaluate product and process impacts.
• Support implementation of preventive measures to reduce recurring quality issues.
• Drive continuous improvement activities using data-driven methodologies.

• Collaborate with Supplier Quality and Operations teams to address quality concerns.
• Support incoming, in-process, and…