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Quality Engineer for Software Development

2 months ago

Pleasanton, California, United States Abbott Full time
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 114,000 colleagues serve people in more than 160 countries.

Job Description

Job Title: Senior Quality Assurance Engineer, Software

About the Role: We are seeking an experienced Senior Software Quality Assurance Engineer to ensure our medical devices are developed in accordance with Abbott's design control requirements and state of the art product standards. The Senior Software Quality Assurance Engineer will serve as a technical representative providing software quality expertise to product development teams.

Key Responsibilities:

  • Complete software quality-related tasks and activities in accordance with quality system requirements.
  • Support software verification and validation activities for new products and software changes in accordance with plans.
  • Participate in meetings to prioritize, review and/or approve of action plans for addressing issues captured in problem resolution systems during development.
  • Perform risk evaluation and associated management activities related to software development.
  • Participate in technical and management reviews to ensure design plans, product design and deliverables related to product software are met.
  • Support non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.
  • May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team.
  • Drive best practices for establishing requirements and completing design verification and validation especially as it relates to user needs.
  • Work as an individual contributor and may provide guidance or oversee work of other QE team members.
  • Support audits and quality system improvement activities.
  • Comply with Abbott, U.S. FDA, EUMDR and other requirements, as applicable.

Requirements:

  • Bachelor's degree, or equivalent experience, in a scientific, technical, or engineering discipline.
  • Minimum 4 years of Software Quality Engineering experience or an equivalent combination of education and experience.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Preferred:
    • Advanced Degree in related discipline.
    • Prior medical device experience.
    • Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
    • Experience with FMEA/risk management.
    • Knowledge of FDA regulations and software guidance, IEC 62304, IEEE 1012, ISO 13485, and ISO14971.

About Abbott: Abbott is an Equal Opportunity Employer, committed to employee diversity. We value people with great ideas who partner with others both internally and externally to accomplish goals.