Quality Engineer I

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

Job summary

Abbott is seeking a Quality Engineer I for the Scarborough, ME site in the Infectious Disease Diagnostics division. You will review qualifications, validations, and quality data to ensure compliance and drive improvements.

The role supports MRB, supplier quality, and audit programs, and develops QA training and test plans. Base pay ranges from $50,700 to $101,300 yearly with standard benefits and travel expectations.

Qualifications

• Bachelor's degree in a technical field or equivalent experience.
• Working knowledge of FDA, cGMP, QSR and ISO quality system requirements.
• Knowledge of quality engineering, investigations, root cause analysis, and process improvement.
• Strong technical writing and problem-solving skills.

Responsibilities

• Review qualifications, validations, and technical studies for content, statistics, sampling plans, and compliance.
• Serve as Quality representative for qualification and validation review and approval.
• Support MRB and nonconforming materials/processes management.
• Disposition nonconforming materials and quality incidents with data and decisions.
• Act as technical resource for timely, customer-focused quality issue resolution.
• Support supplier quality management and documentation.
• Approve reports and design-change documentation; may lead quality-related changes.
• Develop QA training programs and test/inspection plans.
• Review changes from quality and compliance perspectives; collect process data and drive improvement.
• Support internal/external audits and track findings to completion.

Skills

Strong written communication

Analytical thinking

Problem-solving

Technical writing

Education

Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or related

Tools

Minitab

JMP

Quality systems software

Job description

About Abbott

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, 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.

Quality Engineer I Responsibilities

• 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.

Job Details

• 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

Benefits and Compensation

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.

Equal Opportunity Employment

Abbott is an Equal Opportunity Employer, committed to employee diversity. 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.