Quality Engineer I — QA & Process Improvement

Thornton Tomasetti; Scarborough (ME); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott in Scarborough, ME is seeking a Quality Engineer I to support product quality assurance, qualification/validation activities, supplier quality management, and compliance with FDA and ISO requirements.

You will develop test and inspection plans, review nonconforming materials, lead quality‑related design changes when needed, and help build training programs across the Quality organization.

Qualifications

• Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or related technical discipline, or equivalent combination of education and experience.
• Working knowledge of FDA, cGMP, QSR, and ISO quality system requirements.
• Knowledge of quality engineering principles, investigations, root cause analysis, and process improvement methodologies.
• Strong technical writing, analytical, and problem‑solving skills.

Responsibilities

• Reviews qualifications, validations, and technical studies for content, statistics, sampling, unintended impact, and compliance requirements.
• Serves as the Quality representative for qualification and validation review and approval activities.
• Supports the MRB process and maintains processes for managing nonconforming materials and processes.
• Reviews and participates in the disposition of nonconforming materials and quality incidents to ensure appropriate data, testing, documentation, and decisions are completed.
• Acts as a technical resource to support timely and customer‑focused resolution of quality issues.
• Supports supplier quality management activities and maintains supplier quality documentation and processes.
• Reviews and approves reports and documentation associated with design changes and may serve as project lead for quality‑related design change activities.
• Develops and supports Quality Assurance training programs.
• Develops test plans, inspection plans, and quality‑related procedures.
• Reviews manufacturing, process, procedure, and material changes from a quality and compliance perspective.
• Supports process data collection, statistical analysis, and continuous improvement initiatives.
• Supports internal and external audit programs and tracks audit findings through completion.
• Complies with FDA regulations, ISO standards, company policies, operating procedures, and quality system requirements.
• Responsible for utilizing and maintaining the effectiveness of the Quality Management System.
• Maintains positive and collaborative relationships with employees, customers, suppliers, and other business partners.
• Supports Operations and performs related duties and special projects as assigned.

Skills

Quality engineering

Root cause analysis

Process improvement

Technical writing

Analytical skills

Education

Bachelor's degree in a technical field

Tools

Minitab

JMP

Job description

Abbott in Scarborough, ME is seeking a Quality Engineer I to support product quality assurance, qualification/validation activities, supplier quality management, and compliance with FDA and ISO requirements.

You will develop test and inspection plans, review nonconforming materials, lead quality‑related design changes when needed, and help build training programs across the Quality organization.