Senior Software Design Quality Engineer

About the position

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. Our ID Infectious Disease division is currently hiring for a Senior Software Design Quality Engineer in our Tower Center San Diego, CA location. This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for product and non-product software for the division.

Responsibilities

• Reviews pre-defined deliverables/activities as identified in software quality assurance (SWQA) Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan.
• Partner with Design and Manufacturing Engineering teams to complete system/software requirements and other verification and validation tasks.
• Ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, validation and maintenance of product and non-product software.
• Assist in completing and maintaining risk analysis with a focus on software-related risks, including cybersecurity.
• Apply systematic problem-solving methods to identify, prioritize, communicate, and resolve issues.
• Participate in internal and external audits.
• Support all company initiatives as identified by management, ensuring alignment with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements

• Bachelor's Degree Engineering or Technical Field or an equivalent combination of education and work experience.
• Minimum 7 years of Software Quality Engineering experience.
• Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 5-25%, including internationally.

Nice-to-haves

• Experience working in a broader enterprise/cross-division business unit model preferred.
• Detailed knowledge of FDA (including 21 CFR Part 11), GMP, IEC 62304, EN 61010, EN 60601, IVDR, ISO 19471, and ISO 13485 preferred.
• Demonstrated and impactful project management and/or leadership skills, including the ability to serve as a quality team lead and resolve quality-related issues in a timely and effective manner.
• Statistical/data analysis preferred.
• Prior medical device experience ASQ CSQE certification desired.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU 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.