Quality Engineer II providing quality engineering support for AMCOR Packaging Project including validation activities, documentation, and statistical analysis.
Job Requirements
Bachelor’s degree in Engineering or related technical discipline
2–3 years of experience in quality engineering or manufacturing engineering
Hands-on experience with process validation (IQ, OQ, PQ)
Experience performing root cause analysis and supporting CAPA and NCMR activities
Experience with statistical analysis, including process capability studies (Cp, Cpk, Pp, Ppk)
Experience with risk assessment tools such as PFMEA
Experience supporting or executing DR, TMV, and validation quality testing
Preferred Skills
Experience with packaging validation for medical device or similarly regulated products
Familiarity with FDA, ISO 13485, or other regulated quality system standards
Experience creating and maintaining validation protocols and reports
Experience with data analysis tools and statistical software for validation and process capability
Job Responsibilities
Provide Quality Engineering support for the AMCOR Packaging Project from planning through execution and closure
Lead or support development and execution of process validation activities, including IQ, OQ, PQ, TMV, and associated protocols and reports
Coordinate and document DR activities related to packaging and associated processes
Execute and coordinate all validation quality testing and ensure proper documentation and traceability
Perform root cause analysis for nonconformances and support NCMR and CAPA activities to completion
Develop, review, and maintain PFMEA and risk assessments for packaging processes and related equipment
Analyze process and test data to assess process capability and drive validation and process improvement decisions
Ensure validation and quality records meet internal procedures and regulatory requirements
Pay Details: $36.00 to $48.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
Military connected talent encouraged to apply
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