Quality Systems Engineer

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

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 YouTubeJob DescriptionPosition SummaryThe 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 ResponsibilitiesQuality 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 ManagementFacilitate 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 AuditsPlan, 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 ComplianceSupport 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 ManagementLead 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 SupportCollaborate 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 ImprovementDevelop 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 DocumentationSupport 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 QualificationsBachelor'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.Preferred QualificationsCertified 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 CompetenciesRegulatory ComplianceQuality Systems ManagementCAPA and Root Cause AnalysisRisk ManagementInternal AuditingContinuous ImprovementCross-Functional CollaborationTechnical Writing and DocumentationData Analysis and ReportingProject ManagementPhysical RequirementsAbility 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 MeasuresTimely 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 ExpectationsWe 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 teamOur customers grow and prosper from Amcor’s quality, service, and innovationOur investors benefit from Amcor’s consistent growth and superior returnsThe environment is better off because of Amcor’s leadership and productsEqual Opportunity Employer/Minorities/Females/Disabled/Veterans/Sexual Orientation/Gender IdentityAmcor is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.If you would like more information about your EEO rights as an applicant under the law, please click on the \"Know Your Rights: Workplace Discrimination is Illegal\" Poster. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please call 224-313-7000 and let us know the nature of your request and your contact information.E-VerifyWe verify the identity and employment authorization of individuals hired for employment in the United States.BenefitsWhen you join Amcor, you will have access to a comprehensive benefits and compensation package that includes:Medical, dental and vision plansFlexible time off, starting at 80 hours paid time per year for full-time salaried employeesCompany-paid holidays starting at 8 days per year and may vary by locationWellbeing program & Employee Assistance ProgramHealth Savings Account/Flexible Spending AccountLife insurance, AD&D, short-term & long-term disability, and voluntary benefitsPaid Parental LeaveRetirement Savings Plan with company matchTuition Reimbursement (dependent upon approval)Discretionary annual bonus program (initial eligibility dependent upon hire date)