Full time
Americas - North America - United States - Franklin - RPSI Franklin IN
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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
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 requirements, and applicable ISO standards.
Strong analytical, problem-solving, and root cause investigation skills.
Excellent communication, project management, and organizational skills.
Proficiency with Microsoft Office applications and electronic QMS systems.
Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent ASQ certification.
Experience with ISO 13485, ISO 9001, and risk management methodologies.
Lean Six Sigma Green Belt or Black Belt certification.
Experience supporting FDA inspections and external certification audits.
Knowledge of statistical analysis tools and quality data systems.
Experience with validation, process improvement, and manufacturing quality systems.
Key Competencies
Regulatory Compliance
Quality Systems Management
CAPA and Root Cause Analysis
Risk Management
Internal Auditing
Continuous Improvement
Cross-Functional Collaboration
Technical Writing and Documentation
Data Analysis and Reporting
Project Management
Physical Requirements
Ability to work in a manufacturing environment, including cleanroom areas when required.
Ability to sit, stand, and walk for extended periods.
Occasional lifting of up to 25 pounds.
Ability to wear required personal protective equipment (PPE).
Success Measures
Timely closure of CAPAs and audit findings.
Sustained regulatory and certification compliance.
Reduction in recurring quality issues and nonconformances.
Improvement in quality system performance metrics.
Successful support of internal, customer, and regulatory audits.
Continuous improvement of manufacturing quality and operational effectiveness.
Our Expectations
We expect our people to be guided by The Amcor Way and demonstrate our Values every day to enable the business to win. We are winning when:
Our people are engaged and developing as part of a high-performing Amcor team
Our customers grow and prosper from Amcor’s quality, service, and innovation
Our investors benefit from Amcor’s consistent growth and superior returns
The environment is better off because of Amcor’s leadership and products
Apply on Amcor plc’s careers page