Quality Systems Engineer: Customer Complaints & Compliance

Amcor Flexibles, LLC; Mundelein (IL); Presencial; USD 113 000 - 155 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical plan

PTO 80 hours

Paid holidays

Wellbeing program

HSA/FSA

Life insurance

Parental leave

401(k) match

Tuition reimbursement

Bonus program

Resumo da oferta

Amcor Flexibles, LLC in Mundelein, IL seeks a Quality Leader to champion customer-related quality activities and ensure systems meet ISO, GMP and FDA requirements. You will collaborate with QM, operations, IT and engineering to drive corrective actions and plant-wide quality improvements.

Responsibilities include CAPA steering, problem solving with Six Sigma methods, and supporting new product launches with risk assessment and data-driven decisions.

Qualificações

• 3+ years of quality experience in manufacturing or packaging.
• Experience implementing ISO 13485 / ISO 9001 systems.
• Lean/Six Sigma tools and projects experience.
• Knowledge of medical device or pharmaceutical packaging is advantageous.

Responsabilidades

• Establish and maintain relationships with QM and cross functional teams.
• Identify system gaps and propose corrective actions for compliance.
• Investigate customer complaints and drive corrective actions.
• Collaborate with commercial, operations and IT on quality issues.
• Ensure quality systems meet customer specs and regulatory requirements.
• Lead CAPA projects and participate in continuous improvement.
• Support new product launches with quality planning and risk assessment.
• Utilize Six Sigma tools and Kaizen events to deliver improvements.
• Monitor quality performance through data trends and reporting.
• Ensure 95% customer complaint closure within 30 days.

Conhecimentos

Quality management

Regulatory compliance

ISO 13485 / ISO 9001 knowledge

Lean/Six Sigma

Formação académica

Engineering degree (Industrial or Packaging)

Six Sigma Green Belt; ASQ CQE

Ferramentas

Minitab

Lotus Notes

Excel

Word

PowerPoint

Descrição da oferta de emprego

Amcor Flexibles, LLC in Mundelein, IL seeks a Quality Leader to champion customer-related quality activities and ensure systems meet ISO, GMP and FDA requirements. You will collaborate with QM, operations, IT and engineering to drive corrective actions and plant-wide quality improvements.

Responsibilities include CAPA steering, problem solving with Six Sigma methods, and supporting new product launches with risk assessment and data-driven decisions.