Quality Engineer I

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 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.

JOB DESCRIPTION: 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.

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.

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.

JOB FAMILY: Operations Quality DIVISION: ID Infectious Disease LOCATION: United States > Scarborough : 10 Southgate Rd ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis, Work in noisy environment, Work requiring repeated bending, stooping, squatting or kneeling.

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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