Lead Software Quality Assurance Engineer

3 days ago

Kansas City, Missouri, United States Abbott Full time
About the Role

We are seeking a highly skilled Lead Software Quality Engineer to join our team at Abbott, a global healthcare leader. As a key member of our Toxicology Business Unit, you will be responsible for ensuring the quality and compliance of both product and non-product software throughout the software development lifecycle.

Key Responsibilities
  • Ensure that software systems are compliant with applicable Abbott policies and processes for product software design and development, non-product computerized system life cycle (SLC) process, and secure lifecycle process (SLP).
  • Establish Workplace procedures for each SLC phase, including planning, requirements analysis, design, construction and coding, testing and implementation, operations and maintenance, and retirement.
  • Support software verification and validation activities for new products/services and software changes in accordance with plans, including review and approval of software test case protocols and reports, review of software development plans, and review of other system and software documentation.
  • Participate in meetings to prioritize, review, and/or approve action plans for addressing issues captured in Incident/Problem/Defect Reports (IPDRs) during development.
  • Review and approve system risk classification (SRC) and participate in technical and project reviews to ensure design plans, product design, and deliverables related to product software meet requirements.
  • Represent the quality assurance function for the review and approval of applicable software design outputs.
  • Support non-product software verification and validation by assessing the need for supporting protocols, reports, and other documentation as required.
  • Work within Agile software development lifecycle framework and support usability and human factors engineering reviews.
  • Support activities related to software change management and overall change management, provide training and support to team members on Abbott software lifecycle and cybersecurity quality system policies and processes.
  • Support product cybersecurity assessments in conjunction with a cross-functional team and support internal/external audits and quality system improvement activities related to software quality.
  • Ensure compliance with regulatory standards, such as DOT, FDA, ISO 13485, and IEC 62304, as applicable.
Requirements
  • Bachelor's degree in computer science, software engineering, or a related technical field.
  • 5+ years of experience in software quality assurance or software development, preferably in the medical device/IVD industry.
  • Knowledge of Cybersecurity and Data Integrity (ALCOA+) principles, FDA 21 CFR part 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304, and ISO 13485.
  • Advanced computer skills, including statistical/data analysis and report writing, and strong knowledge of software development life cycle (SDLC) and software testing methodologies.
  • Experience with automated testing tools, such as Jira, JAMA, and Azure DevOps, and techniques, and demonstrated experience in leading teams, organizing and managing projects, and developing/coaching/guiding team members.
  • Strong project management skills, ability to multi-task and set priorities to meet overall business objectives, excellent problem-solving and analytical skills, and ability to lead, coach, and mentor QA and IT personnel.
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. We have 114,000 colleagues serving people in more than 160 countries.

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, free medical coverage for employees, an excellent retirement savings plan, tuition reimbursement, and a company recognized as a great place to work in dozens of countries around the world.

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