Quality Systems Engineer

Amcor • Franklin, IN

4d • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.
• 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 final quality activities as needed.
• Monitor quality performance indicators and trend data to identify improvement opportunities.
• Participate in process validation and qualification activities.
• 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.
• 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.

Benefits

• Medical, dental and vision plans
• Flexible time off, starting at 80 hours paid time per year for full-time salaried employees
• Company-paid holidays starting at 8 days per year and may vary by location
• Wellbeing program & Employee Assistance Program
• Health Savings Account/Flexible Spending Account
• Life insurance, AD&D, short-term & long-term disability, and voluntary benefits
• Paid Parental Leave
• Retirement Savings Plan with company match
• Tuition Reimbursement (dependent upon approval)
• Discretionary annual bonus program (initial eligibility dependent upon hire date)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level