Abbott Laboratories
Software Quality Engineer II
Abbott Laboratories, Los Angeles, California, United States, 90079
Overview
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Job Title
Software Quality Engineer II
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.
Health investment plan with an eligible medical plan in the next calendar year.
Excellent retirement savings plan with high employer contribution.
Tuition reimbursement, Freedom 2 Save student debt program and FreeU education benefit.
A company recognized as a great place to work in dozens of countries and named one of the most admired companies by Fortune.
Recognition as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity Our location in Sylmar, CA currently has an opportunity for a
Software Quality Engineer .
This is a fully onsite role.
This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for non-product software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures.
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias.
What You’ll Do
Provide guidance and training to site engineers for Non-Product Software development and validation, Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure compliance for the same.
Collaborate with R&D and Manufacturing Engineering on system/software requirements and verification/validation processes.
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.
Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking systems.
Assist in risk analysis focused on software risks including cybersecurity and data integrity.
Design and implement product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
Apply systematic problem-solving methodologies to identify, prioritize, communicate and resolve issues.
Support internal and external quality audits.
Support Company initiatives in Quality Management Systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements.
Comply with FDA regulations and other regulatory requirements, company policies, and procedures. Maintain positive and cooperative communications with all levels of employees, customers, contractors, and vendors.
Required Qualifications
Bachelor’s Degree in Engineering or Technical Field (Electrical/Computer Engineering preferred) or an equivalent combination of education and work experience.
Minimum 2 years of Software Quality Engineering experience.
Industry certification preferred.
Experience in regulated environments (medical device, diagnostics, or pharmaceutical) and knowledge of US and international quality system requirements (e.g., 21 CFR Part 11, ISO 13485).
Knowledge of quality management techniques and statistics. Strong problem-solving and communication skills. Ability to work independently and cross-functionally.
Programming experience in C/C++, C#, and scripting (e.g., Python). Familiarity with software configuration and issue-tracking tools (GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla).
Knowledge of related regulatory standards (FDA 21 CFR parts 820/11, GMP, IEEE 1012, IEC 62304, ISO 13485).
Advanced computer skills including statistical/data analysis and report writing. Ability to work in a matrixed, geographically diverse environment.
Preferred Qualifications
Medical device experience preferred.
Knowledge of Cybersecurity and Data Integrity (ALCOA+) principles preferred.
Experience with Bluetooth-enabled systems, firmware or embedded software testing and verification/validation preferred.
ASQ CSQE certification desired.
Additional Information Please note that the salary range listed is our full grade range. We usually hire based on the mid-point.
Apply now
Learn more about our health and wellness benefits at: www.abbottbenefits.com
Abbott is an Equal Opportunity Employer and values diversity.
Connect with us at www.abbott.com.
The base pay for this position is $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted.
#J-18808-Ljbffr
Job Title
Software Quality Engineer II
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.
Health investment plan with an eligible medical plan in the next calendar year.
Excellent retirement savings plan with high employer contribution.
Tuition reimbursement, Freedom 2 Save student debt program and FreeU education benefit.
A company recognized as a great place to work in dozens of countries and named one of the most admired companies by Fortune.
Recognition as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity Our location in Sylmar, CA currently has an opportunity for a
Software Quality Engineer .
This is a fully onsite role.
This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for non-product software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures.
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias.
What You’ll Do
Provide guidance and training to site engineers for Non-Product Software development and validation, Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure compliance for the same.
Collaborate with R&D and Manufacturing Engineering on system/software requirements and verification/validation processes.
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.
Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking systems.
Assist in risk analysis focused on software risks including cybersecurity and data integrity.
Design and implement product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
Apply systematic problem-solving methodologies to identify, prioritize, communicate and resolve issues.
Support internal and external quality audits.
Support Company initiatives in Quality Management Systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements.
Comply with FDA regulations and other regulatory requirements, company policies, and procedures. Maintain positive and cooperative communications with all levels of employees, customers, contractors, and vendors.
Required Qualifications
Bachelor’s Degree in Engineering or Technical Field (Electrical/Computer Engineering preferred) or an equivalent combination of education and work experience.
Minimum 2 years of Software Quality Engineering experience.
Industry certification preferred.
Experience in regulated environments (medical device, diagnostics, or pharmaceutical) and knowledge of US and international quality system requirements (e.g., 21 CFR Part 11, ISO 13485).
Knowledge of quality management techniques and statistics. Strong problem-solving and communication skills. Ability to work independently and cross-functionally.
Programming experience in C/C++, C#, and scripting (e.g., Python). Familiarity with software configuration and issue-tracking tools (GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla).
Knowledge of related regulatory standards (FDA 21 CFR parts 820/11, GMP, IEEE 1012, IEC 62304, ISO 13485).
Advanced computer skills including statistical/data analysis and report writing. Ability to work in a matrixed, geographically diverse environment.
Preferred Qualifications
Medical device experience preferred.
Knowledge of Cybersecurity and Data Integrity (ALCOA+) principles preferred.
Experience with Bluetooth-enabled systems, firmware or embedded software testing and verification/validation preferred.
ASQ CSQE certification desired.
Additional Information Please note that the salary range listed is our full grade range. We usually hire based on the mid-point.
Apply now
Learn more about our health and wellness benefits at: www.abbottbenefits.com
Abbott is an Equal Opportunity Employer and values diversity.
Connect with us at www.abbott.com.
The base pay for this position is $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted.
#J-18808-Ljbffr