Quality Engineer I

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

Job summary

Abbott in Scarborough, ME is seeking a Quality Engineer I to support quality assurance activities, process improvements, supplier quality management, and compliance with FDA and ISO requirements within the Infectious Disease Diagnostics division. The role collaborates with Manufacturing, Operations, and Engineering to ensure products and processes meet quality standards.

You will participate in qualification and validation reviews, nonconforming material disposition, data collection, and

Qualifications

• Bachelor's Degree in Engineering or related technical discipline.
• Working knowledge of FDA, cGMP, QSR, ISO quality system requirements.
• Knowledge of quality engineering principles, investigations, root cause analysis, and process improvement methodologies.

Responsibilities

• Review qualifications, validations, and technical studies for content and compliance.
• Serve as Quality representative for qualification and validation review and approval.
• Support MRB processes and disposition of nonconforming materials.
• Review and approve design change reports and lead quality-related design changes.
• Develop and support QA training programs and test/inspection plans.

Skills

Quality engineering

Investigations

Root cause analysis

Technical writing

Education

BS in Engineering

Tools

Minitab

JMP

Job description

JOB DESCRIPTION:

Working at AbbottAt 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, 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 OpportunityThis 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

$50,700.00 – $101,300.00

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 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