Quality Engineer – Medical Devices | FMEA, DOE & SPC

Amcor; Hazleton (Luzerne County); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical, dental and vision plans

Flexible time off

Retirement Savings Plan with company 


Tuition Reimbursement

Discretionary annual bonus

Job summary

Amcor is hiring a Quality Engineer to support manufacturing under ISO 13485, delivering QMS alignment and engineering support. You will participate in IQ/OQ/PQ validations, FMEA, DOE, SPC, and CAPA activities while collaborating across Process Engineering and Operations to drive continual improvement.

The role emphasizes cross-functional teamwork, data-driven problem solving, and adherence to quality metrics to ensure safe access to food, medicine, and goods.

Qualifications

• Bachelor’s degree in Engineering or Science.
• Two or more years of Quality Engineering Experience (medical or food flexible packaging preferred).
• Six Sigma Green or Black Belt certification (preferred) or willingness to pursue.

Responsibilities

• Assisting with process validations (IQ, OQ, & PQ) and product validations as per customer requirements.
• Support manufacturing units with analyzing failures, preventive and corrective action processes related to both internal and external issues.
• Facilitate Failure Mode and Effects Analysis (FMEA).
• Perform Design of Experiments (DOE).
• Track, trend and report quality metrics.
• Provide support for the implementation and sustaining of statistical process controls (SPC).
• Provide support to engineering change order process.
• Assist Quality manager in establishing, implementing and maintaining the quality management system.
• Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.

Skills

Quality engineering

Statistical analysis

Minitab

Communication skills

MS Office

ISO-13485 knowledge

Education

Bachelor's degree in Engineering or Science

Tools

DOE

FMEA

SPC

Job description

Amcor is hiring a Quality Engineer to support manufacturing under ISO 13485, delivering QMS alignment and engineering support. You will participate in IQ/OQ/PQ validations, FMEA, DOE, SPC, and CAPA activities while collaborating across Process Engineering and Operations to drive continual improvement.

The role emphasizes cross-functional teamwork, data-driven problem solving, and adherence to quality metrics to ensure safe access to food, medicine, and goods.