Quality Engineer I

Abbott Laboratories; Scarborough (ME); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Retirement plan

Job summary

Abbott Scarborough, ME, in the Infectious Disease Diagnostics Division, offers a Quality Engineer I role focused on QA activities, process improvements, quality systems, qualification/validation, supplier quality, and FDA/ISO compliance to help ensure product quality.

You will collaborate with Manufacturing, Operations, Engineering and other teams to meet regulatory and quality requirements, supporting audits and continuous improvement initiatives.

Qualifications

• Bachelor’s degree or equivalent in a technical discipline.
• Knowledge of FDA, cGMP, QSR and ISO quality systems.
• Understanding of quality engineering principles and root cause analysis.
• Strong technical writing, analytical and problem-solving skills.

Responsibilities

• Review qualifications, validations, and technical studies for compliance.
• Serve as Quality representative for qualification and validation review.
• Support MRB processes and nonconforming materials.
• Review and approve design-change documentation and lead quality-related design activities.
• Develop test plans, inspection plans, and quality procedures.
• Support internal and external audit programs and track findings.

Skills

FDA/quality system knowledge

Quality engineering

Root cause analysis

Technical writing

Statistical analysis tools (Minitab/Jt

Quality systems software

Education

Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Science or related technical discipline

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Scarborough, ME location in the Infectious Disease, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

The Quality Engineer I role will be responsible for supporting product quality assurance activities, process improvement initiatives, quality system programs, qualification and validation activities, supplier quality management activities, and compliance with applicable FDA and ISO requirements. This position partners with Manufacturing, Operations, Engineering, and other cross-functional teams to ensure products and processes consistently meet quality and regulatory requirements.

What You’ll Work On

• Reviews qualifications, validations, and technical studies for technical content, statistical rationale, sampling plans, unintended impact, and compliance requirements.
• Serves as the Quality representative for qualification and validation review and approval activities.
• Supports the Material Review Board (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.

Required Qualifications

• Bachelor's Degree (BS) in Engineering, Chemistry, Biotechnology, Life Science or other related technical discipline, or equivalent combination of education and experience.
• Working knowledge of FDA, cGMP, Quality System Regulations (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.

Preferred Qualifications

• Experience working within FDA and ISO‑regulated environments.
• Experience with statistical analysis tools such as Minitab or JMP.
• Experience with quality systems software, supplier quality programs, or validation activities.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.