Quality Systems Engineer - CAPA & Compliance

Amcor Limited; Mundelein (IL); On-site; USD 86,000 - 118,000; Full time

Benefits offered by this job

Medical, dental and vision plans

Flexible time off

Company-paid holidays

Wellbeing program

Health Savings Account

Life insurance

Paid parental leave

Retirement Savings Plan with company 1

Tuition Reimbursement

Discretionary annual bonus program

Job summary

Amcor Limited seeks a Quality professional in Mundelein, IL to lead customer complaint resolution, ensure regulatory compliance, and drive quality improvements across cross-functional teams.

You will collaborate with QM, operations, IT and engineering to close gaps, investigate root causes, and implement corrective actions while maintaining ISO 13485/9001 standards and supporting new product launches.

Qualifications

• 3+ years relevant working experience in Quality
• Experience in operations, process engineering and/or process control preferred
• Knowledge of ISO 13485 and ISO 9001
• Knowledge of Medical Device and Pharmaceutical packaging is preferred
• Lean Manufacturing and Six Sigma experience preferred

Responsibilities

• Establish and maintain sound relationships with QM, quality teams and cross functional personnel
• Engage with CAM (Customer Service), operations, IT and engineering personnel to identify system and compliance gaps with proposed resolutions
• Work with operations and other teams to investigate and determine corrective actions related to customer complaints
• Ensure that quality systems satisfy and meet at all times all customer specifications, internal and regulatory requirements (ISO, GMP, FDA)
• Participate in internal and customer related quality activities
• Engage in customer and third party visits and audits
• Responsible for investigating and implementing corrective actions related to customer audit findings
• Review customer specifications and sign off
• Develop quality control plan for products as required
• Demonstrate quality performance by trending and tracking
• Engage in risk assessment process; identification, control and management utilizing risk assessment tools such as FMEA
• Support new product and line launches by working with Sales and Marketing, Engineering and Product Development
• Establish a comprehensive service model for customer complaint resolution
• Participate in CAPA steering committee and lead assigned CAPA and continuous improvement activities
• Utilize Six Sigma tools and participate in Kaizen events to create improvement and permanent positive change
• Engage personnel in problem solving and risk assessments
• Champion, facilitate, participate in projects as assigned
• Follow Amcor policies and procedures at all times with ethical behaviour that delights co-workers, suppliers and other interacted parties
• Work safe and encourage all employees to work safe as well
• Communicate immediately quality issues that bear high risk to the business and customer
• Treat all co-workers with respect and integrity, valuing inputs and feedbacks
• Ensure best practices are identified and shared among Amcor sites
• Identify and communicate effective and efficient risk elimination/mitigation models practiced at Amcor sites
• Meet and exceed target of customer credit dollars
• Meet Customer Complaint closure rate of 95% within 30 calendar days
• Decrease number of customer complaints to meet and exceed current target
• 100% safety record

Skills

Quality management

Lean Manufacturing

Six Sigma

Problem solving

Quality engineering

Education

Engineering degree

Six Sigma Green Belt

ASQ Certified Quality Engineer preferred

Tools

Minitab

Excel

Word

PowerPoint

Lotus Notes

Quality System Software

Job description

Amcor Limited seeks a Quality professional in Mundelein, IL to lead customer complaint resolution, ensure regulatory compliance, and drive quality improvements across cross-functional teams.

You will collaborate with QM, operations, IT and engineering to close gaps, investigate root causes, and implement corrective actions while maintaining ISO 13485/9001 standards and supporting new product launches.