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Sr. Software Quality Engineer

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Abbott Laboratories

CA, US

8 days ago
full-time
degree mentioned

Job highlights

Qualification

Minimum 7 years. Software Quality Engineering experience. Experience with unit- and integration-level testing and automated testing is recommended. Programming experience in C/C++/C#, Scripting Language such as Python. Experience with software configuration, and issue-tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla. Detailed knowledge of FDA part 820, GMP, IEEE 1012, IEC 62304 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing skills. Advanced Information Technology and data mining 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. Ability to leverage and/or engage others to accomplish projects. 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 5-10%, including internationally (if required)

Responsibility

Software Quality Engineer 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. Provide guidance and training to the site engineers for the Software Validation, Data Integrity, Software Requirement Specification (SRS), and also other support software systems.. Work with R&D and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes. Participate in reviews for System and Software requirements with ability to interpret and review system design (hardware, firmware, software) and provide useful feedback. Create and execute or direct software validation protocols traceable to system/software requirements. Execute and support on-time completion of Quality Engineering deliverables: test plans (manual and automated), test scripts (manual and automated), test reports. Use test equipment and instrumentation to obtain test data from the devices and be capable of analyzing the data. Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems. Assist in the completion and maintenance of risk analysis, focused on software related risks including cybersecurity and data integrity risks. Analyze and/or provide feedback on software cybersecurity and data integrity. Review and approve Non-Product Software (NPS) assessment, Data Integrity assessments and Risk Analysis assessment to comply with FDA 21 CFR Part 11. Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing). Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating, and resolving issues. eSupport internal (corporate and divisional) and external quality audit. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Benefits

  • 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 Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
  • Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan
  • Free coverage applies in the next calendar year
  • The base pay for this position is $83,600.00 – $167,200.00
  • In specific locations, the pay range may vary from the range posted
  • Health Insurance
  • Retirement Savings

Job Description

Description

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. 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 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. The Opportunity This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Sr. Software Quality Engineer 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 What You’ll Work On • Provide guidance and training to the site engineers for the Software Validation, Data Integrity, Software Requirement Specification (SRS), and also other support software systems.. • Work with R&D and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes. • Participate in reviews for System and Software requirements with ability to interpret and review system design (hardware, firmware, software) and provide useful feedback. • Create and execute or direct software validation protocols traceable to system/software requirements. Execute and support on-time completion of Quality Engineering deliverables: test plans (manual and automated), test scripts (manual and automated), test reports • Use test equipment and instrumentation to obtain test data from the devices and be capable of analyzing the data • Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems. • Assist in the completion and maintenance of risk analysis, focused on software related risks including cybersecurity and data integrity risks. • Analyze and/or provide feedback on software cybersecurity and data integrity. • Review and approve Non-Product Software (NPS) assessment, Data Integrity assessments and Risk Analysis assessment to comply with FDA 21 CFR Part 11. • Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing). • Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating, and resolving issues. • eSupport internal (corporate and divisional) and external quality audit • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. EDUCATION AND EXPERIENCE YOU’LL BRING • Bachelors Degree Engineering (Electrical/Computer Engineering preferred) or Technical Field OR an equivalent combination of education and work experience • Minimum 7 years • Experience in firmware or embedded software testing and verification/validation preferred. • Software Quality Engineering experience • Cybersecurity and Data Integrity knowledge of SDLC preferred. • Experience working with Bluetooth enabled systems and related software/firmware testing preferred. • Experience with unit- and integration-level testing and automated testing is recommended. • Programming experience in C/C++/C#, Scripting Language such as Python. • Experience with software configuration, and issue-tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla. • Detailed knowledge of FDA part 820, GMP, IEEE 1012, IEC 62304 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing skills. Advanced Information Technology and data mining skills. Prior medical device experience preferred. ASQ CSQE certification desired. • Experience working in a broader enterprise/cross-division business unit model preferred. 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. Ability to leverage and/or engage others to accomplish projects. 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 5-10%, including internationally (if required). Apply Now • Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.