North haven, Connecticut, USA
18 hours ago
Quality Engineer II

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

To read our Candidate Privacy Information Statement, which explains how we will use your information, please

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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