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 114,000 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 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 .

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The position of Software Quality Assurance Engineer is within our Infectious Disease business unit located on site at Westbrook, Maine.

.This role supports the development, implementation, improvement, and/or effectiveness of quality systems in compliance with applicable company, FDA, ISO, and other regulatory agency regulations, policies, and standards through implementation of effective software validation and change control processes.

What You’ll Work On

Completes Software Quality Assurance (SQA) tasks in accordance with current Quality System Requirements.

Subject matter expert for the non-product software lifecycle. Reviews and assesses software activities (suppler evaluations, validation, lifecycle deliverable documents) to ensure compliance with applicable procedures, standards and regulatory requirements.

Participate in software remediation and risk management initiatives.

Works independently according to established objectives. Can plan and coordinate own work according to higher-level project schedules.

Defines validation documentation requirements within the established Software Development Life Cycle (SDLC).

Reviews and approve software lifecycle deliverables.

Provides accuracy, clarity, consistency, completeness, and compliance for multiple projects. Deliverables include System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices, and Verification/Validation Summary Reports for assigned projects.

Reports unexpected events, issues, or software bugs which occur during verification/validation to project team and management and according to established quality processes.

Responsible for implementation and maintenance of assigned software Validation Master Plan(s). 

Communicate laws/regulations, standards, and guidance documents pertaining to software in the medical device industry, with awareness of patient risk, and legal and financial ramifications to customers, the business, and business partners.

Perform other duties & projects as assigned, with relation to compliance and Quality Systems.

Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships

Required Qualifications

Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science, or related technical field or the equivalent combination of education and experience. 

2+ years’ experience in Quality Assurance Regulatory Affairs role in the Medical Device Industry

Knowledge of laws/regulations, standards, and guidance documents pertaining to the medical device industry (i.e. 13485, MDSAP, IVDR, FDA QSR, 14971). In particular, 21 CFR Part 11 and software validation requirements.

Experience in software testing practices, methodologies and techniques, preferably in testing 

Non-Product Software in Medical Device or other regulated industry.

Medical device or regulated industry experience in qualification of computerized/software systems according to accepted industry framework such as GAMP 5, ICH, or ASTM guidelines and principals.

Prior experience working cross-functionally with non-IT technical groups.

Prior project management experience.

Experience partnering with IT to deliver business values.

Preferred Qualifications

Experience with embedded or product software and/or Cybersecurity.

Strong analytical, written, and verbal communication skills and the ability to articulate complex quality and regulatory matters with persons of a variety of backgrounds.

Familiarity with GAMP5 classifications and V-Model

Prior experience with Cloud Technologies

Ability to recognize solid requirements and corresponding tests.

Experience validating Non-Product Software in a highly regulated quality system.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.