Quality Engineer I - Diagnostics QA & Process Improvement

Abbott; Scarborough (ME); On-site; USD 51,000 - 101,000; Full time

Job summary

Abbott in Scarborough, ME is seeking a Quality Engineer I to support quality assurance activities, process improvements, supplier quality management, and compliance with FDA and ISO requirements within the Infectious Disease Diagnostics division. The role collaborates with Manufacturing, Operations, and Engineering to ensure products and processes meet quality standards.

You will participate in qualification and validation reviews, nonconforming material disposition, data collection, and

Qualifications

• Bachelor's Degree in Engineering or related technical discipline.
• Working knowledge of FDA, cGMP, QSR, ISO quality system requirements.
• Knowledge of quality engineering principles, investigations, root cause analysis, and process improvement methodologies.

Responsibilities

• Review qualifications, validations, and technical studies for content and compliance.
• Serve as Quality representative for qualification and validation review and approval.
• Support MRB processes and disposition of nonconforming materials.
• Review and approve design change reports and lead quality-related design changes.
• Develop and support QA training programs and test/inspection plans.

Skills

Quality engineering

Investigations

Root cause analysis

Technical writing

Education

BS in Engineering

Tools

Minitab

JMP

Job description

Abbott in Scarborough, ME is seeking a Quality Engineer I to support quality assurance activities, process improvements, supplier quality management, and compliance with FDA and ISO requirements within the Infectious Disease Diagnostics division. The role collaborates with Manufacturing, Operations, and Engineering to ensure products and processes meet quality standards.

You will participate in qualification and validation reviews, nonconforming material disposition, data collection, and