Medical Device Quality Engineer: Process Validation & FMEA

Amcor LLC; New London (CT); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental and vision plans

Flexible time off

Company-paid holidays

Life insurance

Retirement savings plan with company match

Tuition reimbursement

Job summary

Amcor LLC is looking for a Quality Engineer in New London, Connecticut. This role involves ensuring compliance with quality management systems and customer requirements. Candidates will assist with validations, analyze failures, and improve quality systems using statistical process controls.

Preferred qualifications include a Bachelor’s degree in Engineering or Science and two or more years of relevant experience. Amcor offers benefits such as medical plans, flexible time off, and a retirement savings plan with a company match.

Qualifications

• Two or more years of Quality Engineering experience, preferably in medical or food/packaging.
• Six Sigma Green or Black Belt certification preferred or willingness to pursue.

Responsibilities

• Assist with process validations (IQ, OQ, & PQ) and product validations.
• Support manufacturing units by analyzing failures.
• Facilitate Failure Mode and Effect Analysis (FMEA).
• Track, trend and report quality metrics.
• Lead continual improvement activities to enhance the quality system.

Skills

Quality Management Systems

Statistical Process Control (SPC)

ISO 13485

Excellent interpersonal skills

Minitab

Project Management

Process Validation

Failure Mode and Effect Analysis (FMEA)

Design of Experiments (DOE)

Education

Bachelor’s degree in Engineering or Science

Tools

MS Office

SPC software

Job description

Amcor LLC is looking for a Quality Engineer in New London, Connecticut. This role involves ensuring compliance with quality management systems and customer requirements. Candidates will assist with validations, analyze failures, and improve quality systems using statistical process controls.

Preferred qualifications include a Bachelor’s degree in Engineering or Science and two or more years of relevant experience. Amcor offers benefits such as medical plans, flexible time off, and a retirement savings plan with a company match.