Software Quality Assurance Engineer

3 weeks ago


Westford, Massachusetts, United States Abbott Full time

About the Role

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.

As a Software Quality Assurance Engineer at Abbott, you will play a critical role in ensuring the quality and reliability of our medical device software. You will work closely with cross-functional teams to design, develop, and test software that meets the highest standards of quality and regulatory compliance.

Key Responsibilities

  • Lead, execute and support on-time completion of Quality Engineering deliverables from product concept through commercialization, including but not limited to risk management activities (RMF, FMEA, Cybersecurity Risk Assessment)
  • Support on-time execution of Quality Plans
  • Guide development and documentation of standard operating procedures, specifications and test procedures
  • Support product recertifications
  • CAPA management – including (but not limited to) performing thorough investigations with detailed root-cause analyses with established methods (Fishbone, 5 Why), implementing corrections, corrective actions, creating and monitoring effectiveness criteria.

Requirements

  • Bachelor level degree in Computer science, biomedical engineering, software engineering or a closely related discipline or an equivalent combination of education and work experience.
  • Minimum of 2-5+ years of combined experience in software design quality, cybersecurity design quality is REQUIRED
  • Medical Devices experience in Software is REQUIRED
  • Experience with ISO 14971 is REQUIRED
  • FMEA experience is REQUIRED

What We Offer

  • A fast-paced work environment where your safety is our priority
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match

About Abbott

Abbott is an Equal Opportunity Employer, committed to employee diversity. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call or email.



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