New · posted Oct 29
Abbott · Medical Devices
Quality Engineer I
- Scarborough, ME
- On-site
- Full-time
- Associate & Specialist
The role
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.
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.
What you need
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 Qualificationsnice to have
- 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.
What you'll do
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.
Pay and benefits
$50,700 – $101,300 a year
Employer providedThe base pay for this position is
$50,700.00 – $101,300.00
In specific locations, the pay range may vary from the range posted.
Free medical coverage option through Health Investment Plan (HIP) PPO
Retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit
Career development
Where you'll work
Scarborough, MEOn-siteOpen in Maps (opens in a new tab)
More jobs in Scarborough, MEWorking conditions
Standard
TRAVEL
Yes, 5 % of the Time
MEDICAL SURVEILLANCE
Not Applicable
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.
JOB FAMILY
Operations Quality
DIVISION
ID Infectious Disease
LOCATION
United States > Scarborough : 10 Southgate Rd
From the posting
About Abbott
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.
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
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.
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 kneelingAbbott 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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Job intelligence
The context around this role
Live data · October 29, 2026
Salary intelligence
How the pay compares
This role's midpoint is 6% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US190 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $50,700 | — | $101,300 |
| All US (middle half) | $59,000 | $81,000 | $94,875 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 29, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 975 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk9
- GMP and compliance7
- Documentation and SOPs6
- Lab testing and methods5
- Collaboration and leadership5
- Validation and qualification4
- Investigations and CAPA3
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Abbott on Regulatory Jobs
- 90
- Open roles
- 83
- Distinct roles
- 31
- Locations
By discipline
- Quality60 67%
- Regulatory26 29%
- Compliance & Safety3 3%
By level
- Senior & Principal41 46%
- Associate & Specialist28 31%
- Manager17 19%
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Quality Engineer I at Abbott
Applications close November 10. $51K–$101K a year, employer provided.