Quality Systems Engineer

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

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 everchanging 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, visit www.amcor.com I LinkedIn I Glassdoor I Facebook I YouTube

Job Description

Position Summary

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.

Essential Duties and Responsibilities

Quality Management System (QMS)

• 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.

CAPA Management

• 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.

Internal and External Audits

• 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.

Regulatory Compliance

• 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.

Nonconformance and Risk Management

• 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.

Supplier and Manufacturing Quality Support

• Collaborate with Supplier Quality and Operations teams to address quality concerns.
• Support incoming, in-process, and final quality activities as needed.
• Monitor quality performance indicators and trend data to identify improvement opportunities.
• Participate in process validation and qualification activities.

Quality Metrics and Continuous Improvement

• Develop and maintain quality performance metrics and dashboards.
• Analyze quality data and present findings to management.
• Lead Lean, Six Sigma, and continuous improvement projects.
• Promote a culture of quality and compliance throughout the organization.

Training and Documentation

• Support employee training on quality system requirements and procedures.
• Ensure quality records are complete, accurate, and maintained according to regulatory requirements.
• Assist in developing quality-related training materials and programs.

Required 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.
• Working knowledge of Quality Management Systems and quality engineering principles.
• Experience with CAPA, nonconformance management, change control, document control, and auditing processes.
• Knowledge of FDA regulations, GMP requirem