Abbott
Software Quality Engineer II
Abbott, Los Angeles, California, United States, 90079
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:
A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.Our location in
Sylmar, CA , currently has an opportunity for a
Software Quality Engineer II
.
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.WHAT YOU’LL DOProvide guidance and training to the site engineers for Non-Product Software development and validation, Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure compliance for the same.
Work with R&D and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.
Participate in reviews for Non-product 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
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.
Design and implement various product and process improvement methodologies (i.e, Six Sigma and Lean Manufacturing).
Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues.
Support 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 BRINGBachelors Degree Engineering or Technical Field(Electrical/Computer Engineering preferred) Or an equivalent combination of education and work experience
Minimum 2 years
Software Quality Engineering experience
Prior medical device experience preferred.
Knowledge of Cybersecurity and Data Integrity (ALCOA+) principles preferred.
Experience in Bluetooth enabled systems, firmware or embedded software testing and verification/validation preferred.
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.
Knowledge of FDA 21 CFR part 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing. Advanced Information Technology and data mining skills. ASQ CSQE certification desired.
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.
WHAT WE OFFERAt Abbott, you can have a good job that can grow into a great career. We offer:Training and career development , with onboarding programs for new employees and tuition assistance
Financial security
through competitive compensation, incentives and retirement plans
Health care and well-being programs
including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k)
retirement savings with a generous company match
The stability of a company
with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully:
www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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$65,900.00 – $131,900.00
In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Operations Quality
DIVISION:
CRM Cardiac Rhythm Management
LOCATION:
United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
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)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf#J-18808-Ljbffr
A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.Our location in
Sylmar, CA , currently has an opportunity for a
Software Quality Engineer II
.
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.WHAT YOU’LL DOProvide guidance and training to the site engineers for Non-Product Software development and validation, Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure compliance for the same.
Work with R&D and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.
Participate in reviews for Non-product 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
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.
Design and implement various product and process improvement methodologies (i.e, Six Sigma and Lean Manufacturing).
Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues.
Support 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 BRINGBachelors Degree Engineering or Technical Field(Electrical/Computer Engineering preferred) Or an equivalent combination of education and work experience
Minimum 2 years
Software Quality Engineering experience
Prior medical device experience preferred.
Knowledge of Cybersecurity and Data Integrity (ALCOA+) principles preferred.
Experience in Bluetooth enabled systems, firmware or embedded software testing and verification/validation preferred.
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.
Knowledge of FDA 21 CFR part 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing. Advanced Information Technology and data mining skills. ASQ CSQE certification desired.
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.
WHAT WE OFFERAt Abbott, you can have a good job that can grow into a great career. We offer:Training and career development , with onboarding programs for new employees and tuition assistance
Financial security
through competitive compensation, incentives and retirement plans
Health care and well-being programs
including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k)
retirement savings with a generous company match
The stability of a company
with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully:
www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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$65,900.00 – $131,900.00
In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Operations Quality
DIVISION:
CRM Cardiac Rhythm Management
LOCATION:
United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
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)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf#J-18808-Ljbffr