Senior Software Quality Engineer

2 weeks ago

Atlanta, United States Abbott Full time

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 115,000 colleagues serve people in more than 160 countries.

Job Title

Senior Software Quality Engineer

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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 student debt program and 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.

What You’ll Work On

This position works out of our Pleasanton, CA or Burlington, MA or Atlanta, GA location in the Heart Failure Division. This is an ONSITE position.

In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

We are seeking an experienced to ensure our medical devices are developed in accordance with Abbott’s design control requirements and state of the art product standards. The will serve as a technical representative providing software quality expertise to product development teams. The is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to accomplish goals.

WHAT YOU’LL DO  

Complete SW 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. This includes, but is not limited to, 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 of action plans for addressing issues captured in problem resolution systems during development. Perform risk evaluation and associated management activities related to software development including FMEA, product risk analysis, and mitigation of software issues.  Participate in technical and management reviews to ensure design plans, product design and deliverables related to product software are met. Represent the quality engineering function for the review and approval of designated design outputs. 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.

EDUCATION AND EXPERIENCE YOU’LL BRING  

Required  

Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline. Minimum 4 years of Software Development and/or 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. Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).  Knowledge of FDA regulations and software guidance, IEC 62304, IEEE 1012, ISO 13485, and ISO14971.

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