Lead Software Quality Engineer

3 weeks ago

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

We are seeking a highly skilled Lead Software Quality Engineer to join our team at Abbott Laboratories. 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 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.
  • 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).
  • 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.
  • 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.
  • Support internal/external audits and quality system improvement activities related to software quality.
  • Ensure compliance with regulatory standards, including FDA 21 CFR part 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304, and ISO 13485.
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.
  • Advanced computer skills, including statistical/data analysis and report writing.
  • Strong knowledge of software development life cycle (SDLC) and software testing methodologies.
  • Experience with automated testing tools and techniques.
  • Demonstrated experience in leading teams, organizing and managing projects, and developing/coaching/guiding team members.
  • Strong project management skills and ability to multi-task and set priorities to meet overall business objectives.
  • Excellent problem-solving and analytical skills.
  • Ability to lead, coach, and mentor QA and IT personnel.
Preferred Qualifications
  • Master's degree in a related field.
  • Knowledge of Cybersecurity and Data Integrity (ALCOA+) principles.
  • Knowledge of FDA 21 CFR part 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304, and ISO 13485.
  • 2+ years supervisory experience preferred.
  • Advanced Information Technology and data mining skills.
  • Certification in software quality assurance (e.g., CSQE, CSQA, CMSQ, CAST).
About Abbott Laboratories

Abbott Laboratories 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 are committed to employee diversity and offer a range of benefits, including career development opportunities, free medical coverage, an excellent retirement savings plan, and tuition reimbursement.

Join us at Abbott Laboratories and be part of a team that makes a difference in people's lives.

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