Abbott
Senior Software Design Quality Engineer
Abbott, San Diego, California, United States, 92189
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.
JOB DESCRIPTION:
Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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. 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position is based out of our
San Diego, CA
location. The business group this role resides in is the
Abbott Diagnostics Infectious Disease
team (ARDx ID). We are also open to the person working in
South Portland Maine , or
Lake Forest, IL
offices as well. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. What You’ll Work On This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division. Key Responsibilities: Create and conduct trainings for company personnel on the divisional software development and validation processes. Partner with Design and Manufacturing Engineering teams to complete system/software requirements and other verification and validation tasks. Develop and execute software validation protocols that are traceable to system/software requirements. Implement and manage solutions for code control, including administering Code Control and Software Event/Defect Tracking systems. Assist in completing and maintaining risk analysis with a focus on software-related risks. Design and implement product and process improvement methodologies, such as Six Sigma and Lean Manufacturing. Apply systematic problem-solving methods to identify, prioritize, communicate, and resolve issues. Conduct software scoping and Part 11 audits. Support all company initiatives as identified by management, ensuring alignment with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Required Qualifications Bachelor's Degree in 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 a timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel approximately 5-25%, including internationally. Preferred Qualifications Experience working in a broader enterprise/cross-division business unit model preferred. Detailed knowledge of FDA (including 21 CFR Part 11), GMP, IEEE 1012, IEC 62304, EN 61010, EN 60601 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 preferred. ASQ CSQE certification desired. Strong organizational and follow-up skills, as well as attention to detail. Advanced Information Technology and data mining skills. Prior medical device experience preferred. ASQ CSQE certification desired. 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. 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. JOB FAMILY:
Operations Quality DIVISION:
ID Infectious Disease LOCATION:
United States > San Diego : 4545 Towne Center Court ADDITIONAL LOCATIONS:
United States > Lake Forest : J55, United States > South Portland : 65 Gannett Drive WORK SHIFT:
Standard TRAVEL:
Not specified MEDICAL SURVEILLANCE:
Not Applicable SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday).
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Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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. 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position is based out of our
San Diego, CA
location. The business group this role resides in is the
Abbott Diagnostics Infectious Disease
team (ARDx ID). We are also open to the person working in
South Portland Maine , or
Lake Forest, IL
offices as well. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. What You’ll Work On This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division. Key Responsibilities: Create and conduct trainings for company personnel on the divisional software development and validation processes. Partner with Design and Manufacturing Engineering teams to complete system/software requirements and other verification and validation tasks. Develop and execute software validation protocols that are traceable to system/software requirements. Implement and manage solutions for code control, including administering Code Control and Software Event/Defect Tracking systems. Assist in completing and maintaining risk analysis with a focus on software-related risks. Design and implement product and process improvement methodologies, such as Six Sigma and Lean Manufacturing. Apply systematic problem-solving methods to identify, prioritize, communicate, and resolve issues. Conduct software scoping and Part 11 audits. Support all company initiatives as identified by management, ensuring alignment with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Required Qualifications Bachelor's Degree in 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 a timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel approximately 5-25%, including internationally. Preferred Qualifications Experience working in a broader enterprise/cross-division business unit model preferred. Detailed knowledge of FDA (including 21 CFR Part 11), GMP, IEEE 1012, IEC 62304, EN 61010, EN 60601 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 preferred. ASQ CSQE certification desired. Strong organizational and follow-up skills, as well as attention to detail. Advanced Information Technology and data mining skills. Prior medical device experience preferred. ASQ CSQE certification desired. 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. 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. JOB FAMILY:
Operations Quality DIVISION:
ID Infectious Disease LOCATION:
United States > San Diego : 4545 Towne Center Court ADDITIONAL LOCATIONS:
United States > Lake Forest : J55, United States > South Portland : 65 Gannett Drive WORK SHIFT:
Standard TRAVEL:
Not specified MEDICAL SURVEILLANCE:
Not Applicable SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday).
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