Quality Engineer I - QA & Continuous Improvement

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

Job summary

Abbott is seeking a Quality Engineer I for the Scarborough, ME site in the Infectious Disease Diagnostics division. You will review qualifications, validations, and quality data to ensure compliance and drive improvements.

The role supports MRB, supplier quality, and audit programs, and develops QA training and test plans. Base pay ranges from $50,700 to $101,300 yearly with standard benefits and travel expectations.

Qualifications

• Bachelor's degree in a technical field or equivalent experience.
• Working knowledge of FDA, cGMP, QSR and ISO quality system requirements.
• Knowledge of quality engineering, investigations, root cause analysis, and process improvement.
• Strong technical writing and problem-solving skills.

Responsibilities

• Review qualifications, validations, and technical studies for content, statistics, sampling plans, and compliance.
• Serve as Quality representative for qualification and validation review and approval.
• Support MRB and nonconforming materials/processes management.
• Disposition nonconforming materials and quality incidents with data and decisions.
• Act as technical resource for timely, customer-focused quality issue resolution.
• Support supplier quality management and documentation.
• Approve reports and design-change documentation; may lead quality-related changes.
• Develop QA training programs and test/inspection plans.
• Review changes from quality and compliance perspectives; collect process data and drive improvement.
• Support internal/external audits and track findings to completion.

Skills

Strong written communication

Analytical thinking

Problem-solving

Technical writing

Education

Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or related

Tools

Minitab

JMP

Quality systems software

Job description

Abbott is seeking a Quality Engineer I for the Scarborough, ME site in the Infectious Disease Diagnostics division. You will review qualifications, validations, and quality data to ensure compliance and drive improvements.

The role supports MRB, supplier quality, and audit programs, and develops QA training and test plans. Base pay ranges from $50,700 to $101,300 yearly with standard benefits and travel expectations.